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

Catalog Number	1173118
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	04/23/2025
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by customer that this picc had a crack or hole in it at the 10 cm mark.On (b)(6) 2025, it was found when saline was pushed and there was leakage at the site.After adjusting and pushing more the patient reported some tenderness up the arm and more fluid was noted.The picc was removed and then flushed with saline to identify the hole.No further information 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 complaint of a damaged catheter is confirmed; however, the exact cause is unknown.One 3fr powerpicc sv was returned for evaluation.An initial visual observation showed use residue on the returned sample.A longitudinal split was observed in the catheter tubing between the 8 cm and 9 cm depth markings.A microscopic observation revealed the edges of the split to be straight and the fracture surfaces were observed to flat and granular in texture.The split was observed to align with a linear impression in the surface of the catheter tubing.Slight kinking of the tubing was observed in the area of the split; however, additional factors such as compressional and/or torsional forces may have also contributed to the observed damage.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV (SMALL VEINS), 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22061793
• Report Number: 3006260740-2025-03251
• Device Sequence Number: 18225014
• Product Code: LJS
• UDI-Device Identifier: 00801741086892
• UDI-Public: (01)00801741086892(11)240817(17)251031(10)REJS2555
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 10/31/2025
• Device Catalogue Number: 1173118
• Device Lot Number: REJS2555
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 05/21/2025
• Supplement Report FDA Received Date: 07/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2024
• 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 Age: 63 YR
• Patient Sex: Male