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	Material Frayed (1262)
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 the gauze was fraying.
Additional Manufacturer Narrative
H3: evaluation summary: a device history record (dhr) review was completed for the lot.There were no manufacturing issues related to the complaint for this lot.Samples were received and the sponges were inspected for fraying.There was evidence of raw edges however the edges were within specification.The reported condition of fraying was unconfirmed.The root cause for the raw edges on the product is because the cut edges of the gauze will protrude through the folds or edges, causing the cut edges to become visible outside the edges of the sponge.Sampling plans are in place for production at the beginning, middle and end of the lots run.Inspection for raw edges, fraying and loose threads is part of the checks that are done on every lot.This complaint will be used for tracking and trending purposes.

• 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: 8976820
• Report Number: 1018120-2019-00375
• Device Sequence Number: 3295242
• Product Code: GDY
• UDI-Device Identifier: 10884527016969
• UDI-Public: 10884527016969
• 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: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 196086062
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2019
• Supplement Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/15/2019
• Patient Sequence Number: 1