MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC FT CATHETER W/ SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported l picc placed 7/27 for discharge home antibiotics, returned to ed next day 7/28 kink noted on cxr and observable ¿memory kink¿ noted upon removal.Catheter became "occluded", "kink" in the catheter prevented flushing.We had to replace the piccs in a fairly short timeframe.Additional information received on 11 sept, 2024: patient had to return to the hospital (via ed department) after being discharged a day prior for troubleshooting and replacement of picc.Delay of antibiotic administration.No patient harm or injury.Late antibiotic administration.
Additional Manufacturer Narrative
The manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 catheter kinking was confirmed but the exact cause is unknown.A radiographic image and photograph were returned for evaluation of this complaint.The radiograph showed the left-placed single-lumen picc.The catheter appeared to be kinked at the venous insertion.The photograph showed the implicated 4fr single-lumen powerpicc catheter after it had been removed from the patient.Deformation was seen on the catheter shaft, which appeared to be shape memory from the catheter being kinked.The location of the kink in the catheter in the photograph appeared to align with the kink location seen in the radiograph.The exact cause of the kink in the catheter is unknown.However, it was noted that the insertion angle appeared steep and may have been a contributing factor.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported l picc placed (b)(6) for discharge home antibiotics, returned to ed next day (b)(6) kink noted on cxr and observable ¿memory kink¿ noted upon removal.Catheter became "occluded", "kink" in the catheter prevented flushing.We had to replace the piccs in a fairly short timeframe.Additional information received on 11 sept, 2024: patient had to return to the hospital (via ed department) after being discharged a day prior for troubleshooting and replacement of picc.Delay of antibiotic administration.No patient harm or injury.Late antibiotic administration.

• Brand Name: POWERPICC FT CATHETER W/ SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY
• 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: 20318951
• Report Number: 3006260740-2024-05544
• Device Sequence Number: 8005294
• Product Code: LJS
• UDI-Device Identifier: 00801741034572
• UDI-Public: (01)00801741034572(11)240213(17)250531(10)REJN0735
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2025

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: 1275108FD
• Device Lot Number: REJN0735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 09/27/2024
• Supplement Report FDA Received Date: 03/20/2025
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown