MAUDE Adverse Event Report: TELEFLEX MEDICAL AUTO ENDO5 ML; CLIP, IMPLANTABLE

Catalog Number AE05ML

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

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

It was reported that upon taking the applier out of the box, a puncture was noted through the sterile packaging.

Manufacturer Narrative

Qn#(b)(4).Per dhr the product auto endo5 ml lot # 73l1800544 was manufactured on 11/26/2018 a total of (b)(4) pieces.Lot was released on 11/30/2018.Dhr investigation did not show issues related to complaint.The customer returned one unit ae05ml autoend05 ml for investigation.The returned sample was visually examined with and without magnification.Visual examination of the returned device revealed that the sample was received without its original packaging.The customer stated that the applier was taken out of its packaging.It's unknown whether the packaging was actually returned.It's possible that the packaging was lost during shipping and handling or accidentally discarded during the decontamination process.Since the sample was received without its original packaging, the reported complaint could not be confirmed , and a root cause could not be determined.Since the sample was received without its original packaging, the reported complaint could not be confirmed , and a root cause could not be determined.Therefore, no corrective action is required at this time.The reported complaint of "sterility breached" could not be confirmed based upon the sample received.The sample was received without its original packaging.The customer stated that the applier was taken out of its packaging.It's unknown whether the packaging was actually returned.It's possible that the packaging was lost during shipping and handling or accidentally discarded during the decontamination process.A device history record review was performed with no evidence to suggest a manufacturing related cause.Since the sample was received without its original packaging, the reported complaint could not be confirmed , and a root cause could not be determined.

Event Description

It was reported that upon taking the applier out of the box, a puncture was noted through the sterile packaging.

• Brand Name: AUTO ENDO5 ML
• Type of Device: CLIP, IMPLANTABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8627475
• MDR Text Key: 145629849
• Report Number: 3003898360-2019-00639
• Device Sequence Number: 1
• Product Code: FZP
• Combination Product (y/n): N
• PMA/PMN Number: K152081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

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: 11/18/2021
• Device Catalogue Number: AE05ML
• Device Lot Number: 73L1800544
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 05/21/2019
• Supplement Dates Manufacturer Received: 07/09/2019
• Supplement Dates FDA Received: 07/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1