MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that "doctor inserted 5f double lumen picc.We could not remove the wire.I believe it was was from the purple port but i am not 100% certain anymore." no patient or user impact noted.No other information was provided.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.
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 resistance of a guidewire being removed from a catheter is inconclusive due to the complainant guidewire not being returned with the catheter.One 5 fr d/l powerpicc catheter was returned for evaluation.An initial visual observation showed use residues throughout the returned device, and the complainant nitinol guidewire was not returned with the catheter.A functional test of attempting to insert a non-complainant nitinol guidewire into each lumen revealed slight resistance in the purple lumen, but the functional testing was otherwise unremarkable.Both lumens were then flushed with water using a 12 ml syringe and were both patent to infusion with unremarkable effort and flow rates.The complaint of resistance experienced during the attempt of removal of a guidewire is inconclusive due to the complainant guidewire not being returned with the catheter for testing.
Event or Problem Description
It was reported by the customer that "doctor inserted 5f double lumen picc.We could not remove the wire.I believe it was was from the purple port but i am not 100% certain anymore." no patient or user impact noted.No other information was provided.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY
• 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: 16590583
• Report Number: 3006260740-2023-00955
• Device Sequence Number: 2893329
• Product Code: LJS
• UDI-Device Identifier: 00801741027925
• UDI-Public: (01)00801741027925
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 06/20/2023

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: 3275135
• Device Lot Number: REGX1060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 06/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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