MAUDE Adverse Event Report: COVIDIEN CURITY; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	6822
Medical Device Problem Code	Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Submit date: 10/23/17.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reports that there was only 4 each of sponges in the packaging band which should contain 5 each.
Additional Manufacturer Narrative
An investigation of the reported condition was performed by the supplier for this product.A device history record (dhr) review was completed for the reported lot and it was confirmed that the product was produced accomplishing quality requirements and released according to established procedures.There were no samples or photographs received with this complaint therefore an examination of the reported condition could not be made.Based on the investigation and analysis, the root cause could not be identified due to insufficient information, thus no corrective/preventive action will be taken.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CURITY
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6970028
• Report Number: 3011410703-2017-00433
• Device Sequence Number: 16164555
• Product Code: GDY
• UDI-Device Identifier: 10884521128934
• UDI-Public: 10884521128934
• 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): 04/03/2018

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: Other
• Device Expiration Date: 06/23/2022
• Device Model Number: 6822
• Device Catalogue Number: 6822
• Device Lot Number: 160805
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 10/10/2017
• Initial Report FDA Received Date: 10/23/2017
• Supplement Report FDA Received Date: 04/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1