MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redu3275 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the hemodialysis catheter expected to be used was not used eventually due to the concern resulting from the air leaked from the outer package of the product.

Event Description

It was reported that the hemodialysis catheter expected to be used was not used eventually due to the concern resulting from the air leaked from the outer package of the product.

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a leaking introducer needle was confirmed but the exact cause remains unknown.The product returned for evaluation was one 18 ga introducer needle.The returned product sample was evaluated and the luer connector was observed to be cracked.The fracture features were consistent with outward radiating forces originating within the luer hub orifice, and the characteristics observed which supported this type of failure included: multiple cracks were observed which were longitudinally aligned.Multiple superficial cracks were also seen surrounding the primary damage and were also longitudinally aligned.Functional testing of infusion revealed a leak(s) emanating from the crack(s).Functional testing of aspiration showed that air was drawn into the syringe with test water.It was determined that the forceful insertion of a connecting device may have contributed to the observed damage; however, attempts to replicate this type of failure were unsuccessful which suggested that additional unidentified contributing factors may have also been involved.Consequently, the event was classified as cause unknown.

• Brand Name: NIAGARA SLIM-CATH 15 CM PRE-CURVE KIT
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12442078
• MDR Text Key: 270401308
• Report Number: 3006260740-2021-03709
• Device Sequence Number: 1
• Product Code: MPB
• Combination Product (y/n): N
• PMA/PMN Number: K010778
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 5554150
• Device Lot Number: REDU3275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Date Manufacturer Received: 10/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other