MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SLIM CATH 13F SHORT TERM; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5618150
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that one extension leg of trialysis was collapsed and kinked.It happened right after opening the clamp during insertion procedure.No other information was provided.
Additional 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 that the extension leg collapsed and kinked was confirmed, but the root cause could not be determined.One 15cm trialysis catheter with precurved extension legs was returned for investigation.The catheter exhibited evidence of use.Blood residue was observed in the catheter.The catheter was received with the clamps closed over the extension legs.After opening the clamps, it was observed that the extension legs remained slightly compressed.The arterial extension leg exhibited similar compression near the white strain relief sleeve.A tactual investigation confirmed the compression of the extension legs underneath the clamps.The tubing exhibited preferential kinking at the area of compression.A functional test revealed that the catheter was patent to infusion and no leaks were observed.When the lumens of the catheter were placed under a negative pressure, the extension legs slightly collapsed and the preferential kinking affected the flow rate during aspiration.One contributing factor in the reported event appeared to be material fatigue of the extension legs from repeated or extended clamping.It could not be determined if other factors contributed to the reported extension leg collapse and kinking.
Event or Problem Description
It was reported that one extension leg of trialysis was collapsed and kinked.It happened right after opening the clamp during insertion procedure.No other information was provided.

• Brand Name: POWER-TRIALYSIS SLIM CATH 13F 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: 11152004
• Report Number: 3006260740-2020-21261
• Device Sequence Number: 632333
• 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): 01/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 5618150
• Device Catalogue Number: 5618150
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 04/22/2021
• 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