MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO 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	01/06/2023
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 regs0826 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the director of cath lab that a long coiled hair was found within a sterilized picc kit.It was stated the kit was not used on a patient.No other information was provided.
Event or Problem Description
It was reported by the director of cath lab that a long coiled hair was found within a sterilized picc kit.It was stated the kit was not used on a patient.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 complaint of a fiber in the kit was inconclusive due to the sample condition.Two photographs of a previously opened 5fr d/l powerpicc solo ft catheter kit were returned for evaluation.The kit components appeared unused as most components were within their respective protective packaging sheaths and no residual material from use was noted on the components.A long dark curled fiber was noted in the procedural tray, near the chloraprep and guidewire.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.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC PROVENA SOLO 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16250119
• Report Number: 3006260740-2023-00139
• Device Sequence Number: 6406320
• Product Code: LJS
• UDI-Device Identifier: 00801741155215
• UDI-Public: (01)00801741155215
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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 Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: S1295108FD5
• Device Lot Number: REGS0826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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