MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Crack (1135); Fluid/Blood Leak (1250); Air/Gas in Device (4062)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds2479 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reds2479) have been reported from the same facility in (b)(4).

Event Description

It was reported that performed puncture in this patient.After the introducer needle was attached to syringe, no pressure was felt during aspiration.When performing aspiration, bubbles and fluid leaks were noted at the hub.Immediately replaced with another dialysis catheter, and also no pressure was felt, bubbles and fluid leak still occurred.Replaced with a third dialysis catheter.And the problem was addressed, with no abnormality.This report addresses the first device.

Event Description

It was reported that performed puncture in this patient.After the introducer needle was attached to syringe, no pressure was felt during aspiration.When performing aspiration, bubbles and fluid leaks were noted at the hub.Immediately replaced with another dialysis catheter, and also no pressure was felt, bubbles and fluid leak still occurred.Replaced with a third dialysis catheter.And the problem was addressed, with no abnormality.This report addresses the first device.

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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged needle hub is confirmed; however, the exact cause is unknown.One 18 g introducer needle, one ¿j¿-tip guidewire in a plastic hoop, one 20 cm niagara slimcath catheter with a stiffening stylet inserted in the blue lumen, and two silicone end caps were returned for evaluation.An initial visual observation showed use residue on the returned samples.The hub of the needle was observed to be cracked.A microscopic observation revealed several longitudinal cracks in the hub of the introducer needle.While the cause of the damage observed on the returned sample is unknown, possible contributing factors include forceful insertion of a tapered object into the luer connector hub and material embrittlement due to exposure to incompatible chemicals and/or other environmental conditions.H3 other text : evaluation findings are in section h.11.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS CATHETER KIT 12F X 20CM
• 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: 11215249
• MDR Text Key: 229469163
• Report Number: 3006260740-2020-21413
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045363
• UDI-Public: (01)00801741045363
• 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: 04/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 5553200
• Device Lot Number: REDS2479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/22/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other