MAUDE Adverse Event Report: COVIDIEN SPNG,GAUZE,4 IN X 4 IN,16 PLY,; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7148
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 complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that they received 9 pieces of gauze in a pack instead of 10.
Additional Manufacturer Narrative
A device history record was completed for the reported lot.There were no manufacturing related issues related to the complaint issued for this lot.A sample size of nine individual sponges without the band were received for review.The possible root cause for the miscount could occur if the bundles were checked after the scale is re-set for new batch numbers or moisture adjustments are not compared to the respective control bundle weight.This can cause inaccuracies with the count of the sponges within the bundle.Corrective actions taken were to issue a quality alert to heighten awareness of a potential miscount during manufacturing.The sensors will be checked to ensure that they are functioning correctly for placement and scale resolution will be confirmed to ensure no changes have been made to previous adjustments.

• Brand Name: SPNG,GAUZE,4 IN X 4 IN,16 PLY,
• 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: 9168421
• Report Number: 1018120-2019-00382
• Device Sequence Number: 13994431
• Product Code: GDY
• UDI-Device Identifier: 10884527016969
• UDI-Public: 10884527016969
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2020

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: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 17E092662
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/08/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1