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

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the customer "during picc procedure guidewire was retained into the patient." no other information was provided.Additional information received (b)(6) 2023: approximately 20cm of wire external to venipuncture site.Wire not maintained while picc inserted dilated, wire retained into patient.Tourniquet placed on affected arm, rapid response called, patient had retrieval in ir through femoral vein.Patient stable throughout.Catheter was not inserted as the procedure was aborted.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.

• Brand Name: POWERPICC® CATHETER, 4F SL, 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16590522
• Report Number: 3006260740-2023-00954
• Device Sequence Number: 19588493
• Product Code: LJS
• UDI-Device Identifier: 00801741182532
• UDI-Public: (01)00801741182532
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000887
• Device Lot Number: REGW0916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/01/2023
• Initial Report FDA Received Date: 03/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2022
• 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