MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 NIAGARA SLIM-CATH DIALYSIS 12FX20CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Break (1069); Crack (1135); Gas/Air Leak (2946)

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

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reds3571 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reds3571) have been reported from the same facility in (b)(6).

Event Description

It was reported when using the product, the air leaked when the blood was drawn back with the syringe, and the connector was broken when the syringe was connected, and the blood cannot be drawn.

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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a cracked hub is confirmed but the exact cause remains unknown.One photo sample of two 18 ga introducer needles were provided for evaluation.The pink hubs are show and one of the hubs was observed to be fractured.The second hub could not be clearly inspected from the image provided.The plastic needle covers are present over the needle shafts.Since one of the needle hubs was observed to have a crack, the complaint is confirmed but the exact cause remains unknown.Based on the description of the reported event, possible contributing factors include storage conditions and over-tightening.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported when using the product, the air leaked when the blood was drawn back with the syringe, and the connector was broken when the syringe was connected, and the blood cannot be drawn.

• Brand Name: NIAGARA SLIM-CATH DIALYSIS 12FX20CM
• 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: 11172861
• MDR Text Key: 228204731
• Report Number: 3006260740-2020-21322
• 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: 03/31/2021

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: REDS3571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/24/2020
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/14/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other