MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER TRIALYSIS SHORT TERM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5618150
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redz1756 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that one extension leg of tryalysis was collapsed and kinked.It happened right after opening the clamp during insertion procedure.
Event or Problem Description
It was reported that one extension leg of tryalysis was collapsed and kinked.It happened right after opening the clamp during insertion procedure.
Additional Manufacturer Narrative
H6: investigation summary: the complaint of a kinked extension leg is confirmed but the exact cause remains unknown.Three photo samples of a powertrialysis catheter were provided for evaluation.The first photo sample shows the extension tubing attached to the red hub.A kink in the tubing is visible near the proximal end.Red fluid is present within the tubing and residue is visible on the outer surfaces.The clamp is visible on the distal end of the tubing but cannot be clearly observed.The second photo shows the same kink shown in the first image.The third sample shows the device within a plastic bag outside of patient use.The kink shown in the first two images is visible and an additional bend is also present.Based on the description of the reported event and photo samples provided, possible contributing factors include manipulation of extension leg during use and repeated clamping location.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the extension tubing of the catheter was observed to be kinked, the complaint is confirmed but the exact cause remains unknown.H3 other text : see h.10.

• Brand Name: POWER TRIALYSIS SHORT TERM
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10788481
• Report Number: 3006260740-2020-20385
• Device Sequence Number: 16283401
• Product Code: NIE
• UDI-Device Identifier: 00801741041983
• UDI-Public: (01)00801741041983
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2020

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
• Operator of Device: Health Professional
• Device Model Number: 5618150
• Device Catalogue Number: 5618150
• Device Lot Number: REDZ1756
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 12/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other