MAUDE Adverse Event Report: COVIDIEN DERMACEA X-RAY SPG 4X4 16 PLY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	441601
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 one gauze was missing of the ten that come in the pack.
Additional Manufacturer Narrative
A device history record review could not be performed because the lot number provided by the customer was not valid.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Nine pieces of product with lot#10114119 was returned for investigation.From the investigation, the supplier determined that the worker did not put one each of product resulting in a miscount.Each piece of the product is uneven in weight, and the upper and lower limits is unreasonable therefore the miscount was not found when weighing.The following actions were taken: retraining was provided to the worker that arranges the gauze neatly.Resetting the upper and lower limits of the scale was performed and changes to the error value of the small size product from 1/4 to 1/5.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DERMACEA X-RAY SPG 4X4 16 PLY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9030194
• Report Number: 1282497-2019-08648
• Device Sequence Number: 2882466
• Product Code: GDY
• UDI-Device Identifier: 10884527021239
• UDI-Public: 10884527021239
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2020

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: 441601
• Device Catalogue Number: 441601
• Device Lot Number: 19122801
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/29/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 09/13/2019
• Supplement Report FDA Received Date: 02/06/2020
• Patient Sequence Number: 1