MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Catalog Number UM-05400-B

Device Problem Crack (1135)

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

Event Date 03/29/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

On (b)(6) 2021, happened in the surgery room, the medical staff noticed the needle hub was cracked.Another device was used.

Event Description

On (b)(6) 2021, happened in the surgery room, the medical staff noticed the needle hub was cracked.Another device was used.

Manufacturer Narrative

Qn#(b)(4).The customer reported the needle hub was cracked.The customer returned one opened kit.The epidural needle was removed and visually examined with and without magnification.Visual exanimation revealed the needle appears typical but used.Microscopic examination of the needle revealed the needle's hub appears to have a crack.No other defects or anomalies were observed.Dimensional inspection was not required as a part of this complaint investigation.A manual leak test was performed on the returned needle by plugging the cannula tip and connecting a lab inventory syringe to the luer-lock end of the needle and manually injecting water.A leak could be seen coming from the crack that was observed during the visual examination.No other leaks were detected.Additional testing was not required as a part of this complaint investigation.A device history record review was performed on the epidural needle with no relevant findings.No additional document review was required as a part of this complaint investigation.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the needle hub having a crack was confirmed based on the sample received.Visual examination revealed the needle's hub appeared to have a crack.Functional testing revealed a leak where the crack was observed.A device history record review was performed on the epidural needle with no relevant findings.It is unknown how the needle was handled prior to and during use.The investigation found no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11769485
• MDR Text Key: 248822026
• Report Number: 3006425876-2021-00444
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/26/2022
• Device Catalogue Number: UM-05400-B
• Device Lot Number: 71F20K0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Date Manufacturer Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1