MAUDE Adverse Event Report: COVIDIEN 6022 LAP SPG 18X18 P-W STR; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	6022
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo of the product was provided for evaluation.From the picture, it is not possible to confirm the reported issue.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 reports the plastic tray that should have 5 each only had 4 each.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The physical samples were received for the evaluation.Upon a visual evaluation of the sample, the reported condition was confirmed.The root cause of the missing sponges originates from the vendor process of packing the sponges.When the sponges are delivered to the plant from the vendor, they were wrapped in blue paper for an extra layer of sterility.These blue wrapped packages are then placed in the trays and lidded.There are aql checks that are done beginning, middle and end of each lot from our production.After production there is also finished good testing done.All of these checks are noted in the device history record package.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Photos were provided for the investigation and visually evaluated.Without a physical sample, the reported condition could not be confirmed.Because the reported condition could not be confirmed, the root cause could not be determined.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint file shall be closed as unconfirmed at this time.If the sample(s) is returned at a later date, the complaint shall be reopened, and the investigation will be updated accordingly.

• Brand Name: 6022 LAP SPG 18X18 P-W STR
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 8772526
• Report Number: 1018120-2019-00370
• Device Sequence Number: 11189689
• Product Code: GDY
• UDI-Device Identifier: 10884527020461
• UDI-Public: 10884527020461
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: No Information
• Device Model Number: 6022
• Device Catalogue Number: 6022
• Device Lot Number: 18L190762
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 07/03/2019; 07/03/2019
• Initial Report FDA Received Date: 07/09/2019
• Supplement Report FDA Received Date: 09/03/2019; 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1