MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL W/GUARDIVA, PROBE COVER, & BELDAR NEEDLE GUIDES; 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	Swelling/ Edema (4577)
Date of Event	08/30/2024
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 by the customer that patient came in with a sl picc placed on 7/22.The picc was out 2.5 cm on arrival.When flushing, saline came out the insertion site.On removal, picc was slit at the 4cm mark.Patient denies any damage to the catheter or issues with flushing previously.Very similar symptoms to the other picc we had with this problem.Picc is not in the same lot #.Slit was 1-1.5cm beneath the skin.The impact to the patient was mild swelling to arm and having to have a new picc line placed (unnecessary procedure.
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 3 cm and 4 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 the customer that patient came in with a sl picc placed on 7/22.The picc was out 2.5 cm on arrival.When flushing, saline came out the insertion site.On removal, picc was slit at the 4cm mark.Patient denies any damage to the catheter or issues with flushing previously.Very similar symptoms to the other picc we had with this problem.Picc is not in the same lot #.Slit was 1-1.5cm beneath the skin.The impact to the patient was mild swelling to arm and having to have a new picc line placed (unnecessary procedure.

• Brand Name: POWERPICC SOLO 4F SL W/GUARDIVA, PROBE COVER, & BELDAR NEEDLE GUIDES
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20482047
• Report Number: 3006260740-2024-05987
• Device Sequence Number: 8406458
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997(11)240528(17)250930(10)REJR0537
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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
• 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: 09/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: REJR0537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Supplement Date Received by Manufacturer: 01/10/2025; 04/24/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/25/2025; 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