MAUDE Adverse Event Report: COVIDIEN 3631 LITE SLEEVE; LIGHT, SURGICAL, CEILING MOUNTED

Model Number 31140273

Device Problems Break (1069); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the packaging of the lite sleeves was damaged.Additional information provided stated that the lite sleeves were broken as well.This issue was discovered upon opening the boxes.

Manufacturer Narrative

A device history record of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.A photograph was submitted for evaluation and based on the digital image it was possible to confirm the reported condition; the film and lite sleeves were broken.Although a fed ex label was generated for a return of the physical sample, an actual shipment was never initiated.The potential root cause for the condition is that the material was trapped while sealing the package causing the package to rupture and subsequently resulting in a broken component.A quality alert was initiated to notify to personnel of the condition reported by the customer.A change was made to the inspection level from normal to a heightened level.These changes have been implemented.

• Brand Name: 3631 LITE SLEEVE
• Type of Device: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9708421
• MDR Text Key: 179509370
• Report Number: 9612030-2020-02413
• Device Sequence Number: 1
• Product Code: FSY
• UDI-Device Identifier: 20884527011596
• UDI-Public: 20884527011596
• Combination Product (y/n): N
• 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: 05/01/2020

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: No Information
• Device Model Number: 31140273
• Device Catalogue Number: 31140273
• Device Lot Number: 192463364
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/31/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 05/01/2020
• Patient Sequence Number: 1