MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET: 19 GA; ANESTHESIA CONDUCTION CATHETER

Model Number IPN046378

Device Problem Unsealed Device Packaging (1444)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The doctor did inventory check and found that the package opening was not completely sealed.

Manufacturer Narrative

(b)(4).A device history record review was performed on the lidstock with a potentially relevant finding based on complaint (b)(4).The customer reported the kit was not completely sealed.The customer returned one sealed kit (reference attached files (b)(4)).Visual examination of the returned kit revealed the bottom right corner of the tray appears to be missing adhesive.No other defects or anomalies were observed.A nonconformance has been initiated to further investigate this complaint issue.The reported complaint of the kit not being completely sealed was confirmed based on the sample received.Visual examination of the returned kit revealed the bottom right corner of the tray appeared to be missing adhesive.A device history record review was performed with a potentially relevant finding on the lidstock.Based on the tray missing adhesive, the potential root cause of this complaint issue is manufacturing related.A nonconformance has been initiated to further investigate this issue.

Event Description

The doctor did inventory check and found that the package opening was not completely sealed.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12372511
• MDR Text Key: 268299121
• Report Number: 3006425876-2021-00843
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 40801902128407
• UDI-Public: 40801902128407
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• 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: 08/24/2021

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 Expiration Date: 07/05/2022
• Device Model Number: IPN046378
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F20F2476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2021
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 08/26/2021
• Supplement Dates Manufacturer Received: 10/11/2021
• Supplement Dates FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• 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