MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY (SINGLE-LUMEN); CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number	3194108D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/12/2024
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 is pending evaluation.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported after assessing this picc line, i found that it would flush but i could not get a blood return.I took the dressing off and cut the suture that was holding the picc in place and began pulling the picc.I noticed the picc seemed a little harder to pull than normal.I pulled the picc out to the 20 cm mark and noticed it was leaking.I continued just pull the line the rest of the way due to the crack at the 20 cm mark.This picc was placed in this patient on (b)(6) 2024 and pulled it on (b)(6) 2024.The patient experienced extravasation.The line was used every day up until the day i pulled it.Our infusion department contacted me because they were having trouble getting a blood return from the picc line, but they were able to flush the line just fine.A new line was not placed as the ordering provider decided to treat the patient a different way.No adverse events happened that i am aware of.
Event or Problem Description
It was reported after assessing this picc line, i found that it would flush but i could not get a blood return.I took the dressing off and cut the suture that was holding the picc in place and began pulling the picc.I noticed the picc seemed a little harder to pull than normal.I pulled the picc out to the 20 cm mark and noticed it was leaking.I continued just pull the line the rest of the way due to the crack at the 20 cm mark.This picc was placed in this patient on (b)(6) 2024 and pulled it on (b)(6) 2024.The patient experienced extravasation.The line was used every day up until the day i pulled it.Our infusion department contacted me because they were having trouble getting a blood return from the picc line, but they were able to flush the line just fine.A new line was not placed as the ordering provider decided to treat the patient a different way.No adverse events happened that i am aware of.
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 split in the catheter was confirmed.The product returned for evaluation was one 4 fr s/l powerpicc solo.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 between the 20 cm and 21 cm depth markings.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.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 CATHETER 4F MAXIMAL BARRIER TRAY (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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20881044
• Report Number: 3006260740-2024-07319
• Device Sequence Number: 9043272
• Product Code: LJS
• UDI-Device Identifier: 00801741027727
• UDI-Public: (01)00801741027727(11)240418(17)250731(10)REJP4058
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: 07/31/2025
• Device Catalogue Number: 3194108D
• Device Lot Number: REJP4058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Supplement Date Received by Manufacturer: 01/09/2025; 04/24/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 01/30/2025; 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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