MAUDE Adverse Event Report: ERIKA DE REYNOSA, S.A. DE C.V. STAY SAFE/LUER LOCK ADAPTER 4 IN.; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Catalog Number	050-95005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Peritonitis (2252)
Date of Event	04/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported a patient that was diagnosed with peritonitis.Additional information was obtained through follow-up with the pdrn.The patient was seen in the pd clinic on 25/apr/2024 for a regularly scheduled peritoneal equilibration test (pet).Upon arrival, it was noted that the patient did not have a pin in the extension set.The patient stated that he pinned at the end of treatment; however, the pdrn stated the patient has been very forgetful recently.Additionally, the pd effluent was noted to be cloudy.A pd culture was obtained.The patient was diagnosed with peritonitis and administered intraperitoneal (ip) vancomycin 2g.The patient was initiated on antibiotic therapy with ip ceftazidime daily (dose and duration not provided).The culture came back positive on 29/apr/2024 for pseudomonas aeruginosa.The physician discontinued the ceftazidime and ordered ip cefepime 2g daily for 21 days starting 30/apr/2024.The patient is scheduled for a clinic visit on 02/may/2024 to have the extension set changed.Repeat cultures will be obtained after the completion of the antibiotic therapy.The pdrn stated the cause of the peritonitis was self-inflicted by the patient.The exact source cannot be determined as it could be the missing pin from the extension set, the patient permitting his dogs into the room, or a mistake in aseptic technique due to the patient¿s forgetfulness.The patient did not administer the antibiotics on the 27th or 28th due to forgetting to break the cone in the bag.He did not call the on-call nurse for assistance.The patient will be scheduled for re-training at the clinic and the pdrn will be making a home visit within the next two weeks.
Additional Manufacturer Narrative
Correction: d.4.
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported a patient that was diagnosed with peritonitis.Additional information was obtained through follow-up with the pdrn.The patient was seen in the pd clinic on (b)(6) 2024 for a regularly scheduled peritoneal equilibration test (pet).Upon arrival, it was noted that the patient did not have a pin in the extension set.The patient stated that he pinned at the end of treatment; however, the pdrn stated the patient has been very forgetful recently.Additionally, the pd effluent was noted to be cloudy.A pd culture was obtained.The patient was diagnosed with peritonitis and administered intraperitoneal (ip) vancomycin 2g.The patient was initiated on antibiotic therapy with ip ceftazidime daily (dose and duration not provided).The culture came back positive on (b)(6) 2024 for pseudomonas aeruginosa.The physician discontinued the ceftazidime and ordered ip cefepime 2g daily for 21 days starting on (b)(6) 2024.The patient is scheduled for a clinic visit on (b)(6) 2024 to have the extension set changed.Repeat cultures will be obtained after the completion of the antibiotic therapy.The pdrn stated the cause of the peritonitis was self-inflicted by the patient.The exact source cannot be determined as it could be the missing pin from the extension set, the patient permitting his dogs into the room, or a mistake in aseptic technique due to the patient¿s forgetfulness.The patient did not administer the antibiotics on the (b)(6) due to forgetting to break the cone in the bag.He did not call the on-call nurse for assistance.The patient will be scheduled for re-training at the clinic and the pdrn will be making a home visit within the next two weeks.
Event or Problem Description
A peritoneal dialysis registered nurse (pdrn) reported a patient that was diagnosed with peritonitis.Additional information was obtained through follow-up with the pdrn.The patient was seen in the pd clinic on (b)(6) 2024 for a regularly scheduled peritoneal equilibration test (pet).Upon arrival, it was noted that the patient did not have a pin in the extension set.The patient stated that he pinned at the end of treatment; however, the pdrn stated the patient has been very forgetful recently.Additionally, the pd effluent was noted to be cloudy.A pd culture was obtained.The patient was diagnosed with peritonitis and administered intraperitoneal (ip) vancomycin 2g.The patient was initiated on antibiotic therapy with ip ceftazidime daily (dose and duration not provided).The culture came back positive on (b)(6) 2024 for pseudomonas aeruginosa.The physician discontinued the ceftazidime and ordered ip cefepime 2g daily for 21 days starting (b)(6) 2024.The patient is scheduled for a clinic visit on (b)(6) 2024 to have the extension set changed.Repeat cultures will be obtained after the completion of the antibiotic therapy.The pdrn stated the cause of the peritonitis was self-inflicted by the patient.The exact source cannot be determined as it could be the missing pin from the extension set, the patient permitting his dogs into the room, or a mistake in aseptic technique due to the patient¿s forgetfulness.The patient did not administer the antibiotics on the (b)(6) due to forgetting to break the cone in the bag.He did not call the on-call nurse for assistance.The patient will be scheduled for re-training at the clinic and the pdrn will be making a home visit within the next two weeks.
Additional Manufacturer Narrative
Correction: d.4.

• Brand Name: STAY SAFE/LUER LOCK ADAPTER 4 IN.
• Common Device Name: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): ERIKA DE REYNOSA, S.A. DE C.V.; 1250 south 20th avenue; parque industrial reynosa; safford 85546 ; MX 85546
• MDR Report Key: 19300786
• Report Number: 3023981687-2024-00122
• Device Sequence Number: 6864732
• Product Code: KDJ
• UDI-Device Identifier: 00840861100774
• UDI-Public: 00840861100774
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K173593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024
• Report Date (Section F): 09/04/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 050-95005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/29/2024
• Device Age: MO
• Event Location: Home
• Date Report to Manufacturer: 09/04/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/28/2024; 09/04/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/14/2024; 09/04/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DELFLEX PD FLUID; DELFLEX PD FLUID; DELFLEX PD FLUID; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY CYCLER SET; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER; LIBERTY SELECT CYCLER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male
• Date Report Sent to FDA: 09/04/2024