MAUDE Adverse Event Report: BARD ACCESS SYSTEMS NIAGARA SLIM-CATH PRE-CURVED DUAL-LUMEN DIALYSIS KIT 12F X 15CM; CATHETER, HEMODIALYSIS, NON-IMPLANTED

Model Number N/A

Device Problems Defective Component (2292); Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 12/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rect1884 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when opening the kit, the doctor found that a sheath tip of a introducer needle was damaged.The procedure was completed with another introducer needle with a sheath which was made by other manufacturer.No patient involvement was reported.Note: japan¿s niagara slim catheter kit, unlike us¿s kit, includes a introducer needle with a sheath (iv catheter).

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 damage at the distal tip of the iv catheter was confirmed and the cause appeared to be related to use of the device.The iv catheter and needle from a 16g x 2.70¿ iv catheter and needle set was returned for investigation.The distal edge of the iv catheter had been scored longitudinally with a sharp edge and a portion of the catheter material was hanging from the distal end of the catheter.The observed damage was consistent with the needle tip penetrating the iv catheter material, which may have occurred if the catheter was repositioned over the needle.The catheter and needle length were within specification.Residue from use was observed on the section of needle that was within the iv catheter, which indicates that the product was used.A lot history review (lhr) of rect1884 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when opening the kit, the doctor found that a sheath tip of a introducer needle was damaged.The procedure was completed with another introducer needle with a sheath which was made by other manufacturer.No patient involvement was reported.Note: japan¿s niagara slim catheter kit, unlike us¿s kit, includes a introducer needle with a sheath (iv catheter).

• Brand Name: NIAGARA SLIM-CATH PRE-CURVED DUAL-LUMEN DIALYSIS KIT 12F X 15CM
• Type of Device: CATHETER, HEMODIALYSIS, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9566449
• MDR Text Key: 183563674
• Report Number: 3006260740-2019-04104
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801741045332
• UDI-Public: (01)00801741045332
• Combination Product (y/n): N
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/11/2020

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: 5504150
• Device Lot Number: RECT1884
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/18/2019
• Initial Date FDA Received: 01/08/2020
• Supplement Dates Manufacturer Received: 01/29/2020
• Supplement Dates FDA Received: 02/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1