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

Model Number	N/A
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that on march 10th, while placing a picc, when the inserter was ready to peel-away the microintroducer, it did not peel away completely, necessitating the use of sterile scissors to completely remove the introducer from the picc catheter.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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
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 difficulty breaking the pull tabs on the microintroducer sheath was confirmed but the cause is unknown.Two photographs of the implicated microintroducer sheath were returned for evaluation.The catheter was still partially inlaid within the microintroducer sheath.The pull tabs on the microintroducer sheath had been separated and the sheath had been partially peeled.However, it appeared that the orange tab material did not break cleanly along the pull tab score lines.Some of the visible break edges appeared jagged and irregular instead of straight.A portion of the tab material did not break with the correct pull tab but rather stayed attached to the adjacent pull tab, leaving a small ring of orange material around the catheter.The exact cause of the imperfect break in the handle is unknown.A review of the manufacture quality and inspection records for the implicated product batch indicated no issues potentially related to product manufacture, assembly, and packaging.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that on (b)(6) while placing a picc, when the inserter was ready to peel-away the microintroducer, it did not peel away completely, necessitating the use of sterile scissors to completely remove the introducer from the picc catheter.No other information was provided.Additional information 05/04/2024: it was reported successful picc insertion once microintroducer was properly removed.No patient impact.

• Brand Name: POWERPICC PROVENA SOLO DL 4F 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
• 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 bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19040875
• Report Number: 3006260740-2024-01455
• Device Sequence Number: 12879692
• Product Code: LJS
• UDI-Device Identifier: 00801741222511
• UDI-Public: (01)00801741222511
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 01/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000610A
• Device Lot Number: REHX0459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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