MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-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	07/06/2024
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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that the patient's catheter was found to be ruptured and leaking during drug infusion.No other information was provided.
Event or Problem Description
It was reported that the patient's catheter was found to be ruptured and leaking during drug infusion.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 complaint of a damaged catheter is confirmed; however, the exact cause is unknown.The returned product was one 5 fr dual lumen powerpicc.An initial visual observation showed use residue on the returned sample.The catheter was returned in two pieces and appeared to have been cut at the 24 cm depth marker.Both lumens of the catheter were infused with a 12 ml syringe of water and a leak was observed near the 2 cm depth marker.A microscopic observation revealed a small, jagged, longitudinal split in the catheter near the 2 cm depth marker.The fracture surfaces were observed to be uneven with some linear striations.Additional damage was observed around this split as well as almost directly opposite the spilt; this additional damage was also observed to be jagged but appeared to be superficial.The catheter tubing was also observed to bulge slightly adjacent to the split with a slight linear artifact in the catheter material at the apex of this bulge.Some scratches on the catheter surface suggesting abrasive damage were also observed around the bulging area of the catheter tubing.The physical characteristics, location, and amount of damage observed on the returned sample suggest that the catheter was damaged during use, possibly due to contact with a metallic instrument, due to being compressed, and/or due to exposure to incompatible chemicals.However, there was insufficient evidence to determine the exact mechanism which caused the observed damage.Therefore, the cause of this damage is unknown at this time.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC 5F DUAL-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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19933698
• Report Number: 3006260740-2024-04294
• Device Sequence Number: 16834404
• Product Code: LJS
• UDI-Device Identifier: 00801741027932
• UDI-Public: (01)00801741027932(11)230822(17)270228(10)REHU2347
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2025

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: Other
• Device Model Number: N/A
• Device Catalogue Number: 3275155
• Device Lot Number: REHU2347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 02/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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