MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F FULL TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	3194108
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
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 is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported that on (b)(6) 2024 i placed a powerpicc solo catheter.On (b)(4) 2024 i was called to the infusion department because the picc line was leaking.I took the dressing off and pulled the picc as i flushed it and found 2 cracks in the picc about 5cm up from the hub.The patient said his arm felt full after his last infusion.The picc line was removed and i placed a 2.25 midline in the patient so he could receive his treatment.The following day i placed another picc line in the opposite arm.No other information provided, at this time.
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 was confirmed.The product returned for evaluation was one 4fr single lumen powerpicc solo.The investigation findings are consistent with damage accumulated through flexural fatigue.Flexural fatigue may occur 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 sample was evaluated and two splits were observed between the 4cm and 6cm depth markings.The catheter splits contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned.Fracture edges which were rounded and polished due to repeated material wear.'c' shaped impressions leading into the fracture sites which are consistent with material buckling due to movement which caused the fracture edges to be pressed together.Overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing).Repetitive kinking of the indwelling catheter appears to have contributed to the observed leak; however, the specific circumstances surrounding how kinking developed into a fracture within the catheter tubing were ultimately unknown.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.The damage location suggested that catheter securement, access and maintenance techniques may have contributed.
Event or Problem Description
It was reported that on (b)(6) 2024 i placed a powerpicc solo catheter.On (b)(6) 2024 i was called to the infusion department because the picc line was leaking.I took the dressing off and pulled the picc as i flushed it and found 2 cracks in the picc about 5cm up from the hub.The patient said his arm felt full after his last infusion.The picc line was removed and i placed a 2.25 midline in the patient so he could receive his treatment.The following day i placed another picc line in the opposite arm.No other information provided, at this time.

• Brand Name: POWERPICC SOLO CATHETER 4F FULL TRAY WITH MICROINTRODUCER (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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20708902
• Report Number: 3006260740-2024-06706
• Device Sequence Number: 18195559
• Product Code: LJS
• UDI-Device Identifier: 00801741027710
• UDI-Public: (01)00801741027710(11)231002(17)250131(10)REHV2244
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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: 01/31/2025
• Device Catalogue Number: 3194108
• Device Lot Number: REHV2244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 01/27/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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