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	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regx2173 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 "on day of insertion picc without blood return and difficulty flushing.Line pulled back (tip in atrium) but line continued to have issues.Line declotted about every 2 days until (b)(6) 2023 when line rewired by ir (pt could not tolerate bedside procedure).1/31 referred to onc picc team for evaluation of exchanged ir picc.Line found kinked under statseal ring pulled back and redressed.".
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.
Event or Problem Description
It was reported by the customer "on day of insertion picc without blood return and difficulty flushing.Line pulled back (tip in atrium) but line continued to have issues.Line declotted about every 2 days until (b)(6) 2023 when line rewired by ir (pt could not tolerate bedside procedure).On 1/31 patient was referred to onc picc team for evaluation of exchanged ir picc.Line found kinked under statseal ring pulled back and redressed." no other information was provided.Additional information received 2/28/2023: admission diagnosis is malignant neoplasm of endometrium.Catheter was secured with securacath.Customer reports there was no long-term harm for the patient.
Event or Problem Description
It was reported by the customer "on day of insertion picc without blood return and difficulty flushing.Line pulled back (tip in atrium) but line continued to have issues.Line declotted about every 2 days until (b)(6) 2023 when line rewired by ir (pt could not tolerate bedside procedure).On (b)(6): referred to onc picc team for evaluation of exchanged ir picc.Line found kinked under statseal ring pulled back and redressed." no other information was provided.Additional information received on 2/28/2023: admission diagnosis is malignant neoplasm of endometrium.Catheter was secured with securacath.Customer reports there was no long-term harm for the patient.Additional information received on 5/25/2023: catheter inserted 11cm above the antecubital fossa with 3cm left 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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.

• 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: 16461538
• Report Number: 3006260740-2023-00601
• Device Sequence Number: 12390816
• 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: 2022
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D1
• Device Lot Number: REGX2173
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 02/28/2023; 05/25/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 03/23/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2022
• 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: 74 YR
• Patient Sex: Unknown
• Patient Weight: 72 KG