MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER; 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	05/23/2024
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 device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported, inserted a picc line 4/12.Everything went well.Began leaking a small amount during daily infusion one week ago with difficulty flushing unless arm was down by her side.She came in because all medication was leaking from under the dressing when she did her infusion.When they flushed it, saline shot out of the insertion site.The catheter was only 1 cm out.They did a picc exchange and found the catheter was slightly bent and fractured just before the 5cm mark.It worked for a month.Picc is split on opposite side on where it was bent.No other information was provided.
Event or Problem Description
It was reported, inserted a picc line on (b)(6).Everything went well.Began leaking a small amount during daily infusion one week ago with difficulty flushing unless arm was down by her side.She came in because all medication was leaking from under the dressing when she did her infusion.When they flushed it, saline shot out of the insertion site.The catheter was only 1 cm out.They did a picc exchange and found the catheter was slightly bent and fractured just before the 5cm mark.It worked for a month.Picc is split on opposite side on where it was bent.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 was confirmed and determined to be use related.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 4 cm and 5 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).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.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO 4F SL MAX BARRIER PLUS KIT W/GUARDIVA, PROBE COVER
• 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: 19549670
• Report Number: 3006260740-2024-03053
• Device Sequence Number: 6730912
• Product Code: LJS
• UDI-Device Identifier: 00801741154997
• UDI-Public: (01)00801741154997(11)240305(17)250531(10)REJN3821
• 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: 05/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D3
• Device Lot Number: REJN3821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 09/18/2024; 04/24/2025
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 09/27/2024; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• 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