MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN); 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	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that on january 24, the geriatric nurse found that the puncture site of the picc catheter implanted by the patient had been leaking all the time when changing the fluid, and it was found that the catheter was damaged during extubation, and it was found that there was no leakage after reinsertion.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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported by the customer that on (b)(6), the geriatric nurse found that the puncture site of the picc catheter implanted by the patient had been leaking all the time when changing the fluid, and it was found that the catheter was damaged during extubation, and it was found that there was no leakage after reinsertion.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 leak in the catheters is confirmed and was determined to be use related.One 4fr sl powerpicc catheter were returned for evaluation.The investigation findings are consistent with damage accumulated through flexural fatigue on each sample.Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter.The returned product samples were evaluated and each contained a split within the catheter body.The catheter splits contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was longitudinally aligned along a molding feature; fracture edges which were rounded and polished due to repeated material wear; material buckling due to movement which caused the fracture edges to be pressed together.An examination of the catheter structures revealed no potential damage/defect related to manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC SOLO2 CATHETER BASIC TRAY (4F) (SINGLE-LUMEN)
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18717618
• Report Number: 3006260740-2024-00560
• Device Sequence Number: 20768348
• Product Code: LJS
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 04/23/2024

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: 8194118
• Device Lot Number: REGW3570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 05/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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