MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PRISTINE LONG-TERM HEMODIALYSIS CATHETER

Catalog Number	5403190
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Urinary Tract Infection (2120); Bacteremia (4846)
Date of Event	03/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that "an organism grew in the patient's central line, have not cultured syringe yet.Heparin -3ml 100 unit.".
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device pending return.
Event or Problem Description
It was reported that sometime post chronic catheter placement, central line-associated bloodstream infection was allegedly developed in the patient¿s central line.It was further reported that culture was taken from the line and laboratory infection confirmed the growth of sphingomonas paucimobilis bacteria.Furthermore, patient allegedly experienced symptoms of tachycardia, hypotension, lethargy, and fever.Reportedly, antibiotics were administered to treat central line-associated bloodstream infection.The current status of the patient is unknown.
Event or Problem Description
It was reported that sometime post chronic catheter placement, central line-associated bloodstream infection was allegedly developed in the patient¿s central line.It was further reported that culture was taken from the line and laboratory infection confirmed the growth of sphingomonas paucimobilis bacteria.Furthermore, patient allegedly had urinary tract infection and experienced symptoms of tachycardia, hypotension, lethargy, and fever.Reportedly, antibiotics were administered to treat central line-associated bloodstream infection.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one sealed syringe was returned for evaluation.Gross visual evaluation were performed.Heparin lock flush solution was noted in the syringe.Solution was noted within the syringe.The product was noted to be clean and no other anomalies were noted.The investigation is inconclusive for the reported infection issue as no objective evidence was provided for review.Furthermore, the clinical conditions alleged in the complaint cannot be confirmed.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that sometime post chronic catheter placement, central line-associated bloodstream infection was allegedly developed in the patient¿s central line.It was further reported that culture was taken from the line and laboratory infection confirmed the growth of sphingomonas paucimobilis bacteria.Furthermore, patient allegedly experienced symptoms of tachycardia, hypotension, lethargy, and fever.Reportedly, antibiotics were administered to treat central line-associated bloodstream infection.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2023), g3.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: PRISTINE LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16704341
• Report Number: 3006260740-2023-01238
• Device Sequence Number: 13993631
• Product Code: MSD
• UDI-Device Identifier: 00801741219030
• UDI-Public: (01)00801741219030
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K203767
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/06/2023
• 3 Devices were Involved in the Event: 1 2 3

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 Catalogue Number: 5403190
• Device Lot Number: REFU2820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 07/11/2023; 09/06/2023
• Initial Report FDA Received Date: 04/07/2023
• Supplement Report FDA Received Date: 05/08/2023; 08/08/2023; 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 YR
• Patient Sex: Male
• Patient Weight: 17 KG
• Patient Race: White