MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Backflow (1064)

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

Event Date 09/13/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex1792 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported an 18g ¿ 1.25in intravascular catheter has intermittent issues with the blood control valve, each time we would retract the needle, the catheter would have instant blood flow before connecting the luer-lock.

• Brand Name: ACCUCATH 18GX1.25 BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12580706
• MDR Text Key: 274909523
• Report Number: 3006260740-2021-04145
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• Combination Product (y/n): N
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial
• Report Date: 09/17/2021

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 Model Number: N/A
• Device Catalogue Number: AC0181250
• Device Lot Number: REEX1792
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2021
• Initial Date FDA Received: 10/05/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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