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

Model Number	31140273
Medical Device Problem Codes	Break (1069); Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: LIGHT, SURGICAL, CEILING MOUNTED
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 9708421
• Report Number: 9612030-2020-02413
• Device Sequence Number: 14366010
• Product Code: FSY
• UDI-Device Identifier: 20884527011596
• UDI-Public: 20884527011596
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 31140273
• Device Catalogue Number: 31140273
• Device Lot Number: 192463364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 05/01/2020
• Patient Sequence Number: 1