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	Nonstandard Device (1420)
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 at the manufacturing site 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 there are 2 extra raytec.There was no patient harm.
Additional Manufacturer Narrative
After reviewing the new information provided by the customer and the investigation results, it was determined that this report was submitted in error as the reported product number, lot number and returned sample does not belong to cardinal health.The feeding sets were not leaking.Please disregard report number 1282497-2020-08915.

• 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: 9693426
• Report Number: 1282497-2020-08915
• Device Sequence Number: 13905726
• 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): 04/28/2020

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: 190118-115-SH
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/20/2020
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 04/28/2020
• Patient Sequence Number: 1