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 first device.
Additional Manufacturer Narrative
Based on a review of this information, the following was concluded: the complaint of a bent stylet is confirmed but the root cause could not be determined.One 3cg tls stylet with its extension tubing and plastic spike were returned for evaluation.An initial visual observation revealed the stylet to be pulled about halfway through the septum of the extension tubing.One bend was observed at the distal tip of the stylet at the coating, and a second bend was observed just proximal of the septum.Because it is unknown what difficulties were experienced during the placement of the device, the complaint of a bent stylet is confirmed but the exact cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.Evaluation findings are in section h11.
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 first 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.This medwatch report will address that event.
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: 17596424
• Report Number: 3006260740-2023-03610
• Device Sequence Number: 7552201
• 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,Followup
• Report Date (Section B): 02/05/2024

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?: Device Returned to Manufacturer
• 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: 01/24/2024; 02/01/2024
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 02/01/2024; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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