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	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A batch history review (bhr) of regv0508 showed one other similar product complaint(s) from this batch number.The complaints for this batch number have been reported from the same facility.
Event or Problem Description
It was reported by the customer "r brachial attempted 10 cm above antecubital fossa: line successfully placed and confirmed with ecg; however upon placing dressing red lumen very difficult to flush.Dressing removed and assessed; with no visible kinks: cxr taken to assess tip location, and kink noted in arm.Attempted to retract line to release kink but unsuccessful.New picc line placed." no other information was provided.
Event or Problem Description
It was reported by the customer "r brachial attempted 10 cm above antecubital fossa; line successfully placed and confirmed with ecg, however upon placing dressing red lumen very difficult to flush.Dressing removed and assessed, with no visible kinks; cxr taken to assess tip location, and kink noted in arm.Attempted to retract line to release kink but unsuccessful.New picc line placed." no other information was provided.Additional information received on 5/25/2023: catheter inserted 8cm above the antecubital fossa with 8cm external to the patient.
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 catheter kink is confirmed.One 4 fr dl powerpicc catheters and one radiographic image were returned for evaluation.The image appears to show a link with a sharp bend within the patient's arm.The returned catheter extended up to the 35 cm depth marker.Multiples kinks were noted at the proximal end of the catheter, and at the 6, 8, 9, and 32 cm depth marker.The catheter was then flushed and was found to be occluded when infusing through the red lumen.Microscopic inspection of the kink locations revealed creases and material wrinkling likely caused by the kinks.The catheter was cut in order to measure the lumen dimensions.The catheter wall thickness and lumen spacing were found to be within manufacturing specification.Based on the information provided, it is likely that the kinking of the catheters likely contributed to the complaint of difficulty infusing; therefore, the complaint is confirmed.Additional potential contributing factors include catheter movement during use, patient anatomy and securement technique.

• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16478579
• Report Number: 3006260740-2023-00643
• Device Sequence Number: 3136300
• Product Code: LJS
• UDI-Device Identifier: 00801741154744
• UDI-Public: (01)00801741154744
• 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: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 01/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGV0508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/09/2023
• Supplement Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 03/03/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2022
• 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: 10 YR
• Patient Sex: Unknown
• Patient Weight: 42 KG