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

Model Number	IPN046378
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
The doctor did inventory check and found that the package opening was not completely sealed.
Event or Problem Description
The doctor did inventory check and found that the package opening was not completely sealed.
Additional Manufacturer Narrative
Qn# (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 files (b)(4).Visual examination of the returned kit revealed the bottom portion and the upper left corner of the tray appears to be missing adhesive.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 portion and the upper left 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.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• MDR Report Key: 12372297
• Report Number: 3006425876-2021-00840
• Device Sequence Number: 4334020
• Product Code: BSO
• UDI-Device Identifier: 40801902128407
• UDI-Public: 40801902128407
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/11/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 10/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: N
• Patient Sequence Number: 1