MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, PROBE COVER); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "hair was located in picc tray outside of wrap.Tray was not used." no other information was provided.
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A batch history review (bhr) of regu1681 showed no other similar product complaint(s) from this lot number.
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), packaging, applicable manufacturing records, photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a fiber in the kit was inconclusive due to the sample condition.A photograph of the implicated 4fr d/l powerpicc provena kit was returned for evaluation.The outer header bag had been opened and the tray had been removed from the header bag.The tray was still wrapped within the csr wrap.A long dark wavy fiber was noted on the csr wrap.The fiber appeared consistent with a hair or hair-like material.As the kit had been opened, it could not be independently confirmed if the fiber had been packaged in the kit or if it was introduced into the tray after opening the tray.A review of the manufacture quality and inspection records for the specific lot involved found no potentially related issues encountered during the manufacture and assembly of that product lot.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The report of a foreign material within the packaging has been documented and included in complaint trending.This type of complaint will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.
Event or Problem Description
It was reported by the customer that "hair was located in picc tray outside of wrap.Tray was not used." no other information was provided.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG, GUARDIVA, PROBE COVER)
• 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
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16420717
• Report Number: 3006260740-2023-00504
• Device Sequence Number: 14838677
• Product Code: LJS
• UDI-Device Identifier: 00801741154843
• UDI-Public: (01)00801741154843
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2023

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: S1274108D2
• Device Lot Number: REGU1681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown