MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC PROVENA 4F DL MBPLUS (3CG); 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	05/31/2024
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 failure was first found on (b)(6) 2024, the event continued to occur on multiple dates until the device was removed on (b)(6) 2024.The date reflected in this report is the date bd became aware of the event.The manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported 3/24: 1.5 cm migrated out & not centrally located; 3/25: catheter positionally occluded cxr neg for kink; 4/29: catheter now with 8 cm external; 5/9: catheter 9 cm external; 5/26 catheter d/c'd with kink at 18 cm mark.Due to non-central tip position and migration of line, line with intermittent occlusion and sluggish blood return but did complete therapy.Initially secured with securlock, then statlock.11cm above antecubital fossa 11cm, 4cm external.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 a kinked catheter is confirmed but the root cause could not be determined.One photograph of a catheter was returned for evaluation.An initial visual observation of the photograph showed a kink in the catheter shaft.Use residues were observed along the catheter shaft in the returned photograph.Because no other details of the kink could be evaluated from the returned photograph, the complaint of a kinked catheter is confirmed, but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported on (b)(6): 1.5 cm migrated out and not centrally located; on (b)(6): catheter positionally occluded cxr neg for kink; on (b)(6): catheter now with 8 cm external; on (b)(6): catheter 9 cm external; on (b)(6) catheter d/c'd with kink at 18 cm mark.Due to non-central tip position and migration of line, line with intermittent occlusion and sluggish blood return but did complete therapy.Initially secured with securlock, then statlock.11cm above antecubital fossa 11 cm, 4 cm external.No patient harm reported.No other information was provided.

• Brand Name: POWERPICC PROVENA 4F DL MBPLUS (3CG)
• 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: 19639693
• Report Number: 3006260740-2024-03356
• Device Sequence Number: 17991992
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744(11)230510(17)240630(10)REHQ3503
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• 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): 12/17/2024

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 Expiration Date: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REHQ3503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 12/17/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 01/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• 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: 19 YR
• Patient Sex: Female
• Patient Weight: 105 KG