MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA SOLO; 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	12/05/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "we came across a faulty picc line.We did not recognize it until the picc had been placed and we were doing the fine tuning of where to leave the picc line.The red lumen and only the red lumen started leaking when flushing.It was leaking where the lumen connects to the bard wings that our statlock connects to.We ended up removing the picc and replacing it with another double lumen and didn't have any issues." 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 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 a split in the catheter is confirmed, but the root cause could not be determined.One 4 fr d/l powerpicc solo was returned for evaluation.An initial visual observation of the returned catheter revealed light use residues throughout the returned device.A circumferentially aligned split was observed just distal to the molded suture wings.A microscopic observation revealed the split to have a smooth fracture surface and sharp fracture edges.Whitening was observed on the outer corners of the split site.A circumferential mark was observed on the outside of the split along the split direction.A specific root cause could not be determined from the characteristics of the split under microscopic observations.Potential causes of failure may include contact with a sharp instrument, a split forming during the manufacture of the device, or other unknown conditions.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA SOLO
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21069130
• Report Number: 3006260740-2024-08042
• Device Sequence Number: 3277635
• Product Code: LJS
• UDI-Device Identifier: 00801741220043
• UDI-Public: (01)00801741220043(11)240912(17)250930(10)REJV0238
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2025

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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000931A
• Device Lot Number: REJV0238
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2024
• Supplement Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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