MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET (4F) (SINGLE-LUMEN); 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	12/14/2024
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, "mom unable to flush picc at home.Dressing changed 2 days prior to issue but used yesterday without issues.2 doses of tpa unsuccess for brisk blood return (able flush after first dose).X-ray showed catheter is now brachiocephalic (possible kink in arm).Catheter removed and new line placed.Catheter secured with securacath, 14cm above antecubital fossa, 5cm external.Placed on (b)(6) 2024 and removed on (b)(6) 2024.Patient required ed visit over the weekend.Fortunately, we were able to replace in the ed and did not require an admission.Catheter removed and new line placed.No patient harm reported." no other information was provided.
Event or Problem Description
It was reported, "mom unable to flush picc at home.Dressing changed 2 days prior to issue but used yesterday without issues.2 doses of tpa unsuccess for brisk blood return (able flush after first dose).X-ray showed catheter is now brachiocephalic (possible kink in arm).Catheter removed and new line placed.Catheter secured with securacath, 14cm above antecubital fossa, 5cm external.Placed (b)(6) 2024 and removed (b)(6) 2024.Patient required ed visit over the weekend.Fortunately we were able to replace in the ed and did not require an admission.Catheter removed and new line placed.No patient harm reported." 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 malposition and kinking of the catheter was inconclusive due to the sample condition.The frontal chest radiograph showed a right-sided picc with overlapping of the catheter tubing.Breaks, bends, kinks, and/or looping could neither be confirmed nor excluded.The catheter tip appeared to be overlaying the svc confluence, but the density of the mediastinum made definitive confirmation impossible.The provided radiograph was grainy and difficult to interpret due to the quality of the image.Therefore, the radiograph could not be used to confirm the reported event.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC CATHETER WITH SHERLOCK 3CG (TPS) STYLET (4F) (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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21148100
• Report Number: 3006260740-2024-08401
• Device Sequence Number: 9262859
• Product Code: LJS
• UDI-Device Identifier: 00801741152566
• UDI-Public: (01)00801741152566(11)240620(17)250630(10)REJS0294
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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: 06/30/2025
• Device Model Number: N/A
• Device Catalogue Number: CK000819
• Device Lot Number: REJS0294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2024
• 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 Age: 18 YR
• Patient Sex: Male
• Patient Weight: 86 KG