MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POLYURETHANE, POWERPICC PROVENA SOLO2, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported the diaphragm on the inter luminal wire head was preventing the lumen from flushing or drawing.I attempted to flush it and the diaphragm exploded spraying all of us with saline.Once the wire was removed the catheter was fully functional and in the right place.No other information was provided.
Event or Problem Description
Additional information provided 25 apr 2025: i was the clinician along with the other picc rn who assisted me.No exposure happened because we were in protective gear as dictated by hospital policy for procedures.The concern is that prior to me noticing the defect, we were unable to withdraw blood from the picc line so we spent time repositioning and withdrawing and trying to reposition the picc line to facilitate blood withdraw.On a last attempt while flushing i saw the yellow rubber portion of the luer lock holding the wire bubble out like an aneurysm.I pulled the whole wire out and then the picc flushed and drew without incident.The defect caused an intraprocedural delay and caused us to go down an unnecessary trouble shooting path.
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.
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 the rubber stopper becoming dislodged from the t-lock assembly is confirmed, but the root cause could not be determined.One t-lock assembly was returned for evaluation.An initial visual observation of the returned t-lock extension tubing revealed use residues throughout the device.The stylet was not returned with the device.The rubber stopper was observed to be detached from the plastic t-lock assembly.A microscopic observation revealed no unusual deformation surrounding the plastic of the t-lock assembly, and no unusual deformation was observed along the rubber stopper of the t-lock assembly.Potential causes of failure include over-pressurization of the t-lock assembly or miss assembly during manufacture of the product; however, because the device was used upon the return of the product, the cause of failure could not be determined.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POLYURETHANE, POWERPICC PROVENA SOLO2, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21903858
• Report Number: 3006260740-2025-02565
• Device Sequence Number: 12967144
• Product Code: LJS
• UDI-Device Identifier: 00801741220043
• UDI-Public: (01)00801741220043(11)240930(17)251231(10)REJU1711
• 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,Followup
• Report Date (Section B): 06/25/2025

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: 12/31/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000931A
• Device Lot Number: REJU1711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 06/25/2025
• Initial Report FDA Received Date: 04/24/2025
• Supplement Report FDA Received Date: 05/01/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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