MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG (TPS) STYLET (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	09/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that patient came in for an infusion and the device was leaking at insertion site when flushed.This was pulled and there was a pin hole 2-3 cm done.No other information was provided.Additional information 10/07/2024: picc line placed on (b )(6) 2024 for daily iv antibiotics.Lot number rejr0470.On 9/26 noted blood and fluid leaking around picc insertion site.Inr noted to be 6.1, patient was admitted for observation.Picc pulled on (b)(6) 2024.After pulling picc line, picc nurse flushed pulled picc line with saline to discover a "pinpoint" leak in the tubing in section where picc was tunneled in arm.Replacement of picc line and delay of antibiotics while waiting on picc line.
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.
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 was confirmed.The product returned for evaluation was one 4 fr sl powerpicc solo catheter.The investigation findings are consistent with damage accumulated through flexural fatigue.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 sample was evaluated and a split was observed in the catheter tubing between the 2 cm and 3 cm depth markers.The catheter split 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 site 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.A measurement of the catheter outer diameter, inner diameter and wall thickness were taken.The catheter was found to be within specification.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that patient came in for an infusion and the device was leaking at insertion site when flushed.This was pulled and there was a pin hole 2-3 cm done.No other information was provided.Additional information 10/07/2024: picc line placed on (b)(6) 2024 for daily iv antibiotics.Lot number rejr0470.On (b)(6) noted blood and fluid leaking around picc insertion site.Inr noted to be 6.1, patient was admitted for observation.Picc pulled on (b)(6) 2024.After pulling picc line, picc nurse flushed pulled picc line with saline to discover a "pinpoint" leak in the tubing in section where picc was tunneled in arm.Replacement of picc line and delay of antibiotics while waiting on picc line.

• Brand Name: POWERPICC SOLO2 CATHETER WITH SHERLOCK 3CG (TPS) STYLET (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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20568833
• Report Number: 3006260740-2024-06313
• Device Sequence Number: 7459274
• Product Code: LJS
• UDI-Device Identifier: 00801741154881
• UDI-Public: (01)00801741154881(11)240516(17)250831(10)REJR0470
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2025

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D2
• Device Lot Number: REJR0470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 04/24/2025
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 01/30/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: MDS-24-5154-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown