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

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	06/12/2025
Type of Reportable Event	Malfunction
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.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 by the customer that vat called to replace picc line that patient had removed.Picc supplies were gathered, consent was obtained, and picc procedure was performed.Upon insertion of the picc line and flushing it with 10ml syringes, rn noticed a pin hole leak where the purple hub meets the lavender line.After confirming the line was defective an over-the-wire exchange was performed with a new picc line obtained by the seconding rn.The exchange occurred without incident and the over-the-wire picc line was confirmed to have no defects/issues and functioned properly.
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 leaking catheter is confirmed and was determined to be use-related.One 5 fr t/l powerpicc solo catheter was returned for evaluation.An initial visual observation of the returned catheter showed little use residues throughout the returned catheter.A functional test of infusing water into each lumen using a 12 ml syringe revealed a leak in the red lumen at the catheter/molded joint interface.The white lumen and the gray lumen were observed to be patent to infusion.A microscopic observation revealed a small hole-shaped split at the molded joint/catheter interface.Excess catheter material was observed to be bunched around the edges of the split.The fracture surface appeared smooth with sharp fracture edges.The split fracture surface characteristics were observed to be indicative of damage caused by contact with a instrument such as forceps, hemostats, or other sharp objects.The complaint of a leak in the catheter is confirmed and was determined to be related to the use of the product.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROV THICK TAPER SOLO2, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22385495
• Report Number: 3006260740-2025-04431
• Device Sequence Number: 7100772
• Product Code: LJS
• UDI-Device Identifier: 00801741155222
• UDI-Public: (01)00801741155222(11)250416(17)260228(10)REKQ0115
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 08/20/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: S1395108D5
• Device Lot Number: REKQ0115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/16/2025
• 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: 80 YR
• Patient Sex: Male