MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 5F DL FT 3CG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refq1187 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "we had a peel away sheath that had a hair-like piece attached to it." no other information was provided.
Event or Problem Description
It was reported "we had a peel away sheath that had a hair-like piece attached to it." 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 of a hair on the sheath was not confirmed; however, a strand of sheath material appeared to have given the presence of a foreign fiber.One 5 fr microez microintroducer was provided for evaluation.The device had been peeled and only one section of the red tabs and sheath were returned.Blood residue was visible on the surface of the device.A thin strand of the sheath material was observed to be separated but still bonded to the hub.The strand was observed to narrow and curl near the distal section.Microscopic observation of the parting edge of the sheath revealed it to be smooth and even.The separation of the sheath strand of material from the main piece may have occurred during handling or peeling.Since the strand appeared to have given the presence of a hair, the complaint is confirmed but what caused the strand of material to peel away remains unknown.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC CATHETER 5F DL FT 3CG
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12349099
• Report Number: 3006260740-2021-03429
• Device Sequence Number: 3549333
• Product Code: LJS
• UDI-Device Identifier: 00801741188077
• UDI-Public: (01)00801741188077
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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): 09/28/2021

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: N/A
• Device Catalogue Number: CK000776A
• Device Lot Number: REFQ1187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 09/30/2021
• 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