MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT PROV 4F DL MAX 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	08/03/2023
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 has not been returned to the manufacturer for evaluation.H3 other text : device not returned.
Event or Problem Description
Customer reported 4 dual picc that had a wire crimp in two places.It was a hard picc to place and they competed with ij and pacer wires.Placer had a lot of tension trying to thread and pull back the wire.She had to open up a new kit to be successful dropping the picc line.Additional information received 16 august 2023: event did not involve an urgent/life threatening medical situation.This report addresses the third device.
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.During initial intake of the reported complaint, it appeared that 4 events occurred and 4 medwatch reports were submitted.After additional file review it was determined that the 4 mentioned in the event description was the french size of the catheter and not the quantity of occurrences; only 1 event occurred.Medwatch report 3006260740-2023-03610 will address that event and this medwatch report will be canceled.
Event or Problem Description
Customer reported 4 dual picc that had a wire crimp in two places.It was a hard picc to place and they competed with ij and pacer wires.Placer had a lot of tension trying to thread and pull back the wire.She had to open up a new kit to be successful dropping the picc line.Additional information received 16 august 2023: event did not involve an urgent/life threatening medical situation.

• Brand Name: DOT PROV 4F DL MAX 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17596435
• Report Number: 3006260740-2023-03607
• Device Sequence Number: 17775805
• Product Code: LJS
• UDI-Device Identifier: 00801741130366
• UDI-Public: (01)00801741130366
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2024

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: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: S1274108D
• Device Lot Number: REHN1458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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 Sex: Unknown