MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWER-TRIALYSIS SHORT TERM TL 13F 24CM FULL TRAY; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5605240
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reeu2337 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported a black hair could be seen through the packaging of a dialysis catheter.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, 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 a foreign hair within the kit is inconclusive due to poor sample condition.One photo sample of a 24 cm powertrialysis kit was provided for evaluation.The product label information indicates ref: 5605240; however, the lot number is not visible.The kit packaging appears to be open.A black fiber which appears to be hair is visible on the outer portion of the folded blue drape.The condition and present of the hair prior to kit opening could not be determined; therefore, the complaint could not be confirmed and remains inconclusive at this time.
Event or Problem Description
It was reported a black hair could be seen through the packaging of a dialysis catheter.No other information was provided.

• Brand Name: POWER-TRIALYSIS SHORT TERM TL 13F 24CM FULL TRAY
• 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: 11203256
• Report Number: 3006260740-2021-00039
• Device Sequence Number: 11692257
• Product Code: NIE
• UDI-Device Identifier: 00801741086977
• UDI-Public: (01)00801741086977
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2021

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: 5605240
• Device Catalogue Number: 5605240
• Device Lot Number: REEU2337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2020
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 04/10/2021
• Initial Report FDA Received Date: 01/20/2021
• Supplement Report FDA Received Date: 05/07/2021
• 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