MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Irritability (2421)
Date of Event	04/21/2025
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.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; patient was scheduled for a picc dressing change on (b)(6) (6 days from his previous as pods closed friday (b)(6).Patient's mom called pods (b)(6) to cancel dressing change as family going camping, rebooked for monday (b)(6).Patient arrived to pods (b)(6) at 1400 for picc dressing change.Patient's mom stated patient had been "irritable" and requesting bloodwork.Patient afebrile at 36.5.Writer contacted peds on call dr.For bw orders.Patient's mom stated old sang to picc tubing.Noted large amount of old sang in picc tubing.Attached saline flush, opened picc clamp and aspirated blood into a saline flush.Brisk blood return noted.Attached vacutainer for blood sample but noted vacutainer did not work and tubes would not fill.Around same time, started to notice drops of blood on the towel under patients picc arm, near the picc clamp.Used a chlorhexidine swab to touch around the picc clamp, and chlorhexidine swab was stained with fresh sang - a leak appeared to be around either the picc clamp itself or the tubing around the clamp.Noted a strong indentation in the picc tubing where the clamp must've been clamped.Mom stated patient and dad had been play wrestling while camping and this is when she noticed the blood in the piccs tubing.Ach was contacted and instructed pods staff to remove picc (patient 's oncologist aware).Patient tolerated same well.Picc measured and saved for educator.Additional info / impact of incident: unexpected, prolonged care.No invasive procedure and no apparent harm.Scheduled dressing change postponed at families request.
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 single lumen powerpicc catheter.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 a split was observed in the extension leg tubing, just distal to the luer.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, excessive tensile (pulling) forces, and/or placement/securement technique may have contributed to the observed leak.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22310415
• Report Number: 3006260740-2025-04181
• Device Sequence Number: 15617119
• Product Code: LJS
• UDI-Device Identifier: 00801741027741
• UDI-Public: (01)00801741027741
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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 Model Number: N/A
• Device Catalogue Number: 3194118
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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