MAUDE Adverse Event Report: TELEFLEX MEDICAL HEMOLOK ML CLIPS 6/CART 84/BOX; CLIP, IMPLANTABLE

Model Number IPN028126

Device Problem Unsealed Device Packaging (1444)

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

Event Date 01/20/2021

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

It was reported that on (b)(6) 2021, in (b)(6), the inner package was found not sealed completely, and the customer has concern on the sterility prior to the patient by the nurse head.

Event Description

It was reported that on (b)(6) 2021, in (b)(6), the inner package was found not sealed completely, and the customer has concern on the sterility prior to the patient by the nurse head.

Manufacturer Narrative

Qn#1900082319 per dhr the product hemolok ml clips 6/cart 84/box lot# 73b2000570 was manufactured on 02/25/2020 a total of (b)(4) pieces.Lot was released on 03/17/2020.Dhr investigation did not show issues related to complaint.The customer returned one cartridge 544230 hemolok ml clips 6/cart 84/box for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed that the sample was returned with its packaging partially opened.No issues were found with the integrity of the sterile barrier on the packaging.No other defects could be observed.The sample was sent to the manufacturing site for further investigation.It was found that the package did not present porosity or lack of seal in the exposed part of the packaging.Additionally, the burst test record was reviewed and no issues were found.Based on the condition of the returned sample, the complaint issue could not be confirmed and a root cause could not be determined.A corrective action is not required at this time as the complaint issue could not be confirmed.The sample was returned partially opened and there were no issues found with the sterile barrier.The reported complaint of "incomplete seal - sterility compromised" could not be confirmed.Visual inspection showed that the sample was returned partially opened.No issues were found with the integrity of the sterile barrier on the packaging.The sample was sent to the manufacturing site for further investigation.It was found that the package did not present porosity or lack of seal in the exposed part of the packaging.Additionally, the burst test record was reviewed and no issues were found.Therefore, based on the condition of the returned sample, the complaint issue could not be confirmed and a root cause could not be determined.

• Brand Name: HEMOLOK ML CLIPS 6/CART 84/BOX
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11304923
• MDR Text Key: 231173413
• Report Number: 3003898360-2021-00104
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 34026704625193
• UDI-Public: 34026704625193
• Combination Product (y/n): N
• PMA/PMN Number: K133202
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028126
• Device Catalogue Number: 544230
• Device Lot Number: 73B2000570
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1