MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX, INC. FLEX TIP PLUS EPIDURAL CATHERIZATION KIT ANESTHESIA CONDUCTION KIT

Catalog Number AK-05502

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/17/2019

Event Type  Injury  

Event Description

Epidural catheter was resistant to come out after a delivery via c-section. Two physicians arrived, and one attempted to remove the catheter. After initial progress the device broke. The physician informed the patient what had happened, and told her it would require surgery to remove the device. Fda safety report id# (b)(4).

• Brand Name: FLEX TIP PLUS EPIDURAL CATHERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC (SUBSIDIARY OF TELEFLEX, INC.
• MDR Report Key: 8866187
• MDR Text Key: 153648130
• Report Number: MW5088825
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/31/2020
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F19A0372
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 08/05/2019 Patient Sequence Number: 1