MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT; 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	12/29/2023
Type of Reportable Event	Malfunction
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported, ¿i found a hair in a 5fr picc kit stuck in a blade.I can assure you that it wasn¿t our hair.¿ no other information was provided.Additional information provided 01/12/2024: it was reported, ¿i had to switch out the kit.We found the hair in the middle of the procedure.No patient impact.¿.
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 complaint of a foreign material is inconclusive due to the state of the returned sample.One photograph of a kit tray was returned for evaluation.An initial visual observation of the photograph showed an open kit tray with a hair in one of the compartments.Use residue was observed on some of the kit components in the returned photograph.While a hair was observed in the kit tray, it was not possible to determine when or where the kit came into contact with the hair.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported, ¿i found a hair in a 5fr picc kit stuck in a blade.I can assure you that it wasn¿t our hair.¿ no other information was provided.Additional information provided 01/12/2024: it was reported, ¿i had to switch out the kit.We found the hair in the middle of the procedure.No patient impact.¿.

• Brand Name: POWERPICC PROVENA 5F DL FT MAX BARRIER PLUS KIT
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18603392
• Report Number: 3006260740-2024-00215
• Device Sequence Number: 2821273
• Product Code: LJS
• UDI-Device Identifier: 00801741155161
• UDI-Public: (01)00801741155161
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• 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): 03/15/2024

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 Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S1275108FD5
• Device Lot Number: REHS4206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2024
• Supplement Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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