MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; 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	03/08/2023
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 on 3/20/2023: a sl 5fr picc line was inserted and found to be backing up with blood and leaking at the hub/needleless connector.The catheter was secured with statlock.There was no break.Patient received rocephin infusions through the picc as an outpatient.Clinician states the picc was noted to barely leak with flushing saline, but not with infusion of rocephin for some time.The ir doctor was notified and cleared the line for use.The clinician states that from their understanding, several weeks later after returning home from his daily rocephin infusion, the patient called, stating that the picc was leaking and backed up with blood.Patient was instructed to return to the cath lab and the sl picc was removed and a new dl picc was placed.There were no signs or symptoms or other complications.The event did not involve an urgent or life-threatening medical situation.
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.

• Brand Name: POWERPICC 5F SINGLE-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• 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: 16691388
• Report Number: 3006260740-2023-01201
• Device Sequence Number: 7454530
• 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: 2023
• Device Explanted Year: 2023
• 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: 43 YR
• Patient Sex: Male
• Patient Weight: 71 KG