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

Model Number	CK000738
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
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 refr0279 showed no similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "a lot of hair is in the kit." 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 foreign material in the kit is inconclusive due to poor sample condition.One photo sample of an opened 5 fr tl powerpicc catheter kit was provided for evaluation.The sticker ¿stop¿ sign is present on what appears to be the external clear plastic packaging that is adhered to the external surface of the picc kit.The contents of the picc kit were removed from the packaging.Multiple strands of hair appear to be present on the clear plastic material.The condition of the kit tray and components prior to opening could not be determined from the image.Based on the information provided, possible contributing factors include deposition of material during kit packaging or during kit handling.Since the condition and presence of hair prior to kit opening could not be determined, the complaint could not be confirmed and remains inconclusive at this time.Evaluation findings are in section h.11.
Event or Problem Description
It was reported "a lot of hair is in the kit." no other information was provided.

• Brand Name: DOT PPICC 5F TL TT 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: 12315729
• Report Number: 3006260740-2021-03273
• Device Sequence Number: 19960288
• Product Code: LJS
• UDI-Device Identifier: 00801741139512
• UDI-Public: (01)00801741139512
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• 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): 09/15/2021

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: CK000738
• Device Catalogue Number: CK000738
• Device Lot Number: REFR0279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2021
• Initial Date Received by Manufacturer: 07/22/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/24/2021
• 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