MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH; MIDLINE CATHETER

Model Number N/A

Device Problem Difficult or Delayed Separation (4044)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported the microintroducer is serrating at tip of the sheath.No other information was provided.

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 lot history review (lhr) of regv3234 showed no other similar product complaint(s) from this lot number.

• Brand Name: 4FR DL PROVENA MIDLINE MAX BARRIER KIT W/BIOPATCH
• 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: 15973946
• MDR Text Key: 308131804
• Report Number: 3006260740-2022-05702
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741154164
• UDI-Public: (01)00801741154164
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: S4254108BDP
• Device Lot Number: REGV3234
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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