MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STERILE STAY SAFE CAP; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95012
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Codes	Diarrhea (1811); Fever (1858); Low Blood Pressure/ Hypotension (1914); Peritonitis (2252); Cramp(s) /Muscle Spasm(s) (4521); Decreased Appetite (4569)
Date of Event	02/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A registered nurse (rn) reported that a patient on peritoneal dialysis (pd) developed an infection on (b)(6) 2023 characterized by fever, diarrhea, cramping, poor appetite and hypotension.The rn stated the infection was caused by an issue with 2 lots of the fresenius stay safe caps.The patient was receiving antibiotics in the outpatient pd clinic.In an additional follow-up call, the reporting nurse confirmed the patient was experiencing symptoms (noted above) on the morning of (b)(6) 2023.As a result, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture yielded growth of the organism paracoccus yeei.The patient was treated with intra-peritoneal (ip) vancomycin (per clinic dosing) on an outpatient basis.The nurse indicated the patient recovered from the peritonitis event.The patient continues pd therapy with the same cycler and a new box of stay safe caps (provided by the outpatient pd clinic) without further reported issues.The nurse stated the peritonitis is not related to any fluid leaks or any issues with the fresenius cycler/cycler set.The nurse alleged the patient received two boxes of defective stay safe cap with lot #d1zd201& d1zd071.Per the nurse, upon visual inspection of the stay safe caps there are no observable defects.However, the nurse stated that when attaching the stay safe cap to the end of the pd catheter (not a fresenius product) the iodine filled sponge inside the cap disintegrates.The nurse provided that the pd clinic has the two boxes of the involved stay safe caps available for return to manufacturer.
Additional Manufacturer Narrative
Clinical review: a temporal relationship exists between pd therapy with the fresenius stay safe cap and the patient¿s peritonitis event.Peritonitis is a well-documented potential complication in patients undergoing pd therapy.The patient¿s pd nurse alleged the peritonitis was caused by defective stay safe caps ( lot #d1zd201& d1zd071) whereby the iodine filled sponge inside the cap disintegrated upon attaching to the pd catheter (not a fresenius product).At the time of this clinical investigation, the manufacturer product analysis of the stay safe caps is pending.Therefore, based on the nature of the reported event, the stay safe cap can be excluded as a causal factor in this event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.
Additional Manufacturer Narrative
Additional information: h.10.International plant investigation: the complaint samples were requested and investigated.The samples were checked physically in regard to the described failure.The sponge inside the caps were present in all returned samples 20pcs of batch d1zd071.No abnormalities were detected.Batch record investigation (dhr): 480 000 products of batch d1zd071 have been inspected according to the inspection protocol, were found conforming to specifications, and have been released without any discrepancies.No indication for any relationship with the reported failure mode has been found during the review.The investigation of the available iodine was within the specified limits.Based on the complaint description we assume a handling issue as the reason for the complaint, which could have been caused by a user related circumstance.The returned samples showed no deviation in regard of the description of a "disintegrated sponge" which might have been caused by a misinterpretation of the visual appearance.The reason for the complaint could not be clarified by this investigation.
Event or Problem Description
A registered nurse (rn) reported that a patient on peritoneal dialysis (pd) developed an infection on (b)(6), 2023 characterized by fever, diarrhea, cramping, poor appetite and hypotension.The rn stated the infection was caused by an issue with 2 lots of the fresenius stay safe caps.The patient was receiving antibiotics in the outpatient pd clinic.In an additional follow-up call, the reporting nurse confirmed the patient was experiencing symptoms (noted above) on the morning of (b)(6), 2023.As a result, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture yielded growth of the organism paracoccus yeei.The patient was treated with intra-peritoneal (ip) vancomycin (per clinic dosing) on an outpatient basis.The nurse indicated the patient recovered from the peritonitis event.The patient continues pd therapy with the same cycler and a new box of stay safe caps (provided by the outpatient pd clinic) without further reported issues.The nurse stated the peritonitis is not related to any fluid leaks or any issues with the fresenius cycler/cycler set.The patient has a fresenius extension set that is attached to the pd catheter (not a fresenius product).The patient uses a new stay safe cap at the end of treatment that is attached to the fresenius extension set.The nurse alleged the patient received two boxes of defective stay safe cap with lot #d1zd201& d1zd071.Per the nurse, upon visual inspection of the stay safe caps there are no observable defects.However, the nurse stated that when attaching the stay safe cap to the end of fresenius extension set the iodine filled sponge inside the cap disintegrates.The nurse provided that the pd clinic has the two boxes of the involved stay safe caps available for return to manufacturer.
Event or Problem Description
A registered nurse (rn) reported that a patient on peritoneal dialysis (pd) developed an infection on (b)(6) 2023 characterized by fever, diarrhea, cramping, poor appetite and hypotension.The rn stated the infection was caused by an issue with 2 lots of the fresenius stay safe caps.The patient was receiving antibiotics in the outpatient pd clinic.In an additional follow-up call, the reporting nurse confirmed the patient was experiencing symptoms (noted above) on the morning of (b)(6) 2023.As a result, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture yielded growth of the organism paracoccus yeei.The patient was treated with intra-peritoneal (ip) vancomycin (per clinic dosing) on an outpatient basis.The nurse indicated the patient recovered from the peritonitis event.The patient continues pd therapy with the same cycler and a new box of stay safe caps (provided by the outpatient pd clinic) without further reported issues.The nurse stated the peritonitis is not related to any fluid leaks or any issues with the fresenius cycler/cycler set.The patient has a fresenius extension set that is attached to the pd catheter (not a fresenius product).The patient uses a new stay safe cap at the end of treatment that is attached to the fresenius extension set.The nurse alleged the patient received two boxes of defective stay safe cap with lot #d1zd201 and d1zd071.Per the nurse, upon visual inspection of the stay safe caps there are no observable defects.However, the nurse stated that when attaching the stay safe cap to the end of fresenius extension set the iodine filled sponge inside the cap disintegrates.The nurse provided that the pd clinic has the two boxes of the involved stay safe caps available for return to manufacturer.
Additional Manufacturer Narrative
Plant investigation: actual devices were returned to the manufacturer for physical investigation.Product samples from the customer with original package identified with reported model and lot number.During the visual inspection it was found that eight of the forty samples received do not have enough iodine, however this appearance is because the sponge has a closer contact to the wall on one side of the cap which makes the impression that there might be not enough iodine in the cap.This circumstance is not a sign of a low amount of iodine.Additionally, a functional and dimensional tests were performed to verify if the samples did not have enough iodine, if a leak is present or if the sponge disintegrates while the catheter connection is done.During the tests no leaks were found, the sponge is in good condition and the percentage of iodine presented in the samples was within the acceptable range.The sample tested worked as intended without any abnormalities.During the evaluation of the samples, the alleged failure stated in the complaint was not confirmed.A review of the device manufacturing records was conducted by the manufacturer.There were no deviations or non-conformances during the manufacturing process.In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements.There is no causal relationship between the product and the reported peritonitis.
Event or Problem Description
A registered nurse (rn) reported that a patient on peritoneal dialysis (pd) developed an infection on (b)(6) 2023 characterized by fever, diarrhea, cramping, poor appetite and hypotension.The rn stated the infection was caused by an issue with 2 lots of the fresenius stay safe caps.The patient was receiving antibiotics in the outpatient pd clinic.In an additional follow-up call, the reporting nurse confirmed the patient was experiencing symptoms (noted above) on the morning of (b)(6) 2023.As a result, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture yielded growth of the organism paracoccus yeei.The patient was treated with intra-peritoneal (ip) vancomycin (per clinic dosing) on an outpatient basis.The nurse indicated the patient recovered from the peritonitis event.The patient continues pd therapy with the same cycler and a new box of stay safe caps (provided by the outpatient pd clinic) without further reported issues.The nurse stated the peritonitis is not related to any fluid leaks or any issues with the fresenius cycler/cycler set.The patient has a fresenius extension set that is attached to the pd catheter (not a fresenius product).The patient uses a new stay safe cap at the end of treatment that is attached to the fresenius extension set.The nurse alleged the patient received two boxes of defective stay safe cap with lot #d1zd201 & d1zd071.Per the nurse, upon visual inspection of the stay safe caps there are no observable defects.However, the nurse stated that when attaching the stay safe cap to the end of fresenius extension set the iodine filled sponge inside the cap disintegrates.The nurse provided that the pd clinic has the two boxes of the involved stay safe caps available for return to manufacturer.
Additional Manufacturer Narrative
Correction: b.5., b.7., d.10, and h.10.Clinical review: a temporal relationship exists between pd therapy with the fresenius stay safe cap and the patient¿s peritonitis event.Peritonitis is a well-documented potential complication in patients undergoing pd therapy.The patient¿s pd nurse alleged the peritonitis was caused by defective stay safe caps (lot #d1zd201& d1zd071) whereby the iodine filled sponge inside the cap disintegrated upon attaching to the fresenius extension set.At the time of this clinical investigation, the manufacturer product analysis of the stay safe caps is pending.Therefore, based on the nature of the reported event, the stay safe cap cannot be excluded as a causal factor in this event.
Event or Problem Description
A registered nurse (rn) reported that a patient on peritoneal dialysis (pd) developed an infection on (b)(6)2023 characterized by fever, diarrhea, cramping, poor appetite and hypotension.The rn stated the infection was caused by an issue with 2 lots of the fresenius stay safe caps.The patient was receiving antibiotics in the outpatient pd clinic.In an additional follow-up call, the reporting nurse confirmed the patient was experiencing symptoms (noted above) on the morning of (b)(6)2023.As a result, the patient was seen in the outpatient pd clinic and had a pd culture obtained.Per the nurse, the pd culture yielded growth of the organism paracoccus yeei.The patient was treated with intra-peritoneal (ip) vancomycin (per clinic dosing) on an outpatient basis.The nurse indicated the patient recovered from the peritonitis event.The patient continues pd therapy with the same cycler and a new box of stay safe caps (provided by the outpatient pd clinic) without further reported issues.The nurse stated the peritonitis is not related to any fluid leaks or any issues with the fresenius cycler/cycler set.The patient has a fresenius extension set that is attached to the pd catheter (not a fresenius product).The patient uses a new stay safe cap at the end of treatment that is attached to the fresenius extension set.The nurse alleged the patient received two boxes of defective stay safe cap with lot #d1zd201& d1zd071.Per the nurse, upon visual inspection of the stay safe caps there are no observable defects.However, the nurse stated that when attaching the stay safe cap to the end of fresenius extension set the iodine filled sponge inside the cap disintegrates.The nurse provided that the pd clinic has the two boxes of the involved stay safe caps available for return to manufacturer.

• Brand Name: STERILE STAY SAFE CAP
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; mike allen #1331; parque industrial reynosa; reynosa UT 88780 ; MX 88780
• Manufacturer (Section G): ERIKA DE REYNOSA, S.A. DE C.V.; director, quality systems; 900 w zaragosa drive suite d; pharr TX 78577
• Manufacturer Contact: jessica trujillo ; 920 winter st; waltham, MA 02451 ; 6174175172
• MDR Report Key: 16530448
• Report Number: 0008030665-2023-00269
• Device Sequence Number: 19494259
• Product Code: KDJ
• UDI-Device Identifier: 00840861100835
• UDI-Public: 00840861100835
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K083542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 050-95012
• Device Lot Number: D1ZD071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2023
• Supplement Date Received by Manufacturer: 03/15/2023; 03/22/2023; 03/28/2023; 07/01/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 03/21/2023; 03/23/2023; 04/24/2023; 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; STAY SAFE CATHETER EXTENSION SET; STAY SAFE CATHETER EXTENSION SET; STAY SAFE CATHETER EXTENSION SET; STAY SAFE CATHETER EXTENSION SET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female