MAUDE Adverse Event Report: C. R. BARD, INC. ACCUCATH ACE INTRAVASCULAR CATHETER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Lot Number REFQ 1278

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2021

Event Type  malfunction  

Event Description

Upon placement of a 20 g accucath in the rfa the guide wire (gw) was being removed the nurse felt slight resistance and then a release of the gw.The tip of the catheter (coil) broke off and remained in the pt's vein.Bard notified and noted that the failure could be related to me lot refq 1278.Subject; 3110943 - pir3017146 - acknowledgment, sample, lot number verification and additional information requested.Our ref : 3110943, external ref: pir3017146, date of incident: (b)(6) 2021, date reported: 06/20/2021.Part name: accucath 22 gx1.25, part no: ac0221250, batch no:, lot provided: refq1278.Description of complaint - it was reported "customer alerted me wire broke off when placing accucath, no pt harm.".

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 12107826
• MDR Text Key: 260148347
• Report Number: MW5102256
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REFQ 1278
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 111