MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY 70 CM GUIDEWIRE; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that a defective single picc line was recovered.The patient had to have the picc line replaced with double lumen that did not leak.Additional information received 3/20/2023: single lumen 5f picc line inserted, found to be leaking at hub/needleless connector.The catheter was secured with statlock.There was no break in the catheter; the nurse noticed it leaked at the hub when flushed.There was no clinical delay in treatment but the patient did have another procedure to exchange the picc for a dl picc.No signs or symptoms or other complications occurred.Ancef was infused through the picc but the clinician reports the picc was noted to leak just with flushing with saline.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY 70 CM GUIDEWIRE
• 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: 16691386
• Report Number: 3006260740-2023-01200
• Device Sequence Number: 7454529
• Product Code: LJS
• UDI-Device Identifier: 00801741027697
• UDI-Public: (01)00801741027697
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/22/2023

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: 10/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 3175335
• Device Lot Number: REFY3552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/15/2023
• Initial Report FDA Received Date: 04/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2021
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 76 KG