MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number IPN038423

Device Problems Material Fragmentation (1261); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/31/2020

Event Type  malfunction  

Event Description

The patient was admitted to labor and delivery.An epidural catheter was being placed in preparation for a planned c-section.The toughy needle was placed.Upon attempting to thread the catheter, at approximately 2 cm into the toughy needle, resistance was felt.Re-threading of catheter was attempted, but was unsuccessful when resistance was again felt at 2 cm.Upon removing the catheter from the needle, approximately 5mm of circular metal fragments were noted.The fragments looked similar to circular pencil sharpener shavings, but were naturally much smaller.A new epidural catheter kit was opened, and the epidural was easily inserted.The tip of the original toughy introducer needle was intact, as was the catheter they attempted to thread.Since the team was not certain whether any metal fragments had been pushed into the patient and retained under the skin, they obtained an x-ray following delivery, with the consent of the patient, to ensure no metal fragments were present.

• Brand Name: ARROW FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10493500
• MDR Text Key: 205672005
• Report Number: 10493500
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2020

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: IPN038423
• Device Catalogue Number: ASK-05500-JHH1
• Device Lot Number: 23F20D0344
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/02/2020
• Date Report to Manufacturer: 09/04/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 8395 DA
• Patient Weight: 75