MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT 3FR SL PROV ML; MIDLINE CATHETER

Model Number N/A

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of regp1017 showed four other similar product complaint(s) from this lot number.

Event Description

It was reported by the customer that "the micro introducer sheath to accordion or fold back upon insertion through the skin." no other information was provided.

• Brand Name: DOT 3FR SL PROV ML
• Type of Device: MIDLINE CATHETER
• 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: 16088376
• MDR Text Key: 308393214
• Report Number: 3006260740-2022-05962
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741185076
• UDI-Public: (01)00801741185076
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SP4153108DB
• Device Lot Number: REGP1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2022
• Initial Date FDA Received: 01/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other