MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO 4F SL W/BIOPATCH, 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
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 that the patients previous picc was having issues and needed to be replaced.Rn, placed the new line (b)(6) 2024.Picc team was notified on monday 8/ 5 from the local doctors office stating there was no blood return and they were unable to get labs but they did a xray to confirm placement and the tip of the picc was in the right place.Patient returned back to the facility on 8/7 and picc team confirmed no placement so a repeat xray was done and it showed a kink in two places (kink was around the 2cm and 6-7cm.Rn then went to assess the site, and when the dressing was removed the picc line dislodged out (reported about 2 cm came out).When they went to flush the line, saline was leaking out of the insertion point.Picc was then removed and a fracture was noted around the 2cm and 6cm mark.Was told that when the 7/10 picc was placed, the patient went from being weeks of bed bound to ambulatory with 24-7 walker assistance.No other information was provided.
Event or Problem Description
It was reported that the patients previous picc was having issues and needed to be replaced.Rn, placed the new line (b)(6) 24.Picc team was notified on monday (b)(6) from the local doctors office stating there was no blood return and they were unable to get labs but they did a xray to confirm placement and the tip of the picc was in the right place.Patient returned back to the facility on (b)(6) and picc team confirmed no placement so a repeat xray was done and it showed a kink in two places (kink was around the 2cm and 6-7cm.Rn then went to assess the site, and when the dressing was removed the picc line dislodged out (reported about 2 cm came out).When they went to flush the line, saline was leaking out of the insertion point.Picc was then removed and a fracture was noted around the 2cm and 6cm mark.Was told that when the (b)(6) picc was placed, the patient went from being weeks of bed bound to ambulatory with 24-7 walker assistance.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 is confirmed and was determined to be use related.One 4 fr sl powerpicc solo catheter was returned for evaluation.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 between the 2 and 3 cm markers and a secondary split at the 6cm marker in the catheter body.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.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 W/BIOPATCH, 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20091325
• Report Number: 3006260740-2024-04792
• Device Sequence Number: 7847589
• Product Code: LJS
• UDI-Device Identifier: 00801741155192
• UDI-Public: (01)00801741155192
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 1194108D5
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 11/22/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown