MAUDE Adverse Event Report: COVIDIEN 7462 VISTEC SPG 8X4 12P T-10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	7462
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Urinary Retention (2119); 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 the pack was supposed to have 10 sponges, but only had 9.
Additional Manufacturer Narrative
Section h6 field has been corrected: 2119 urinary retention was inadvertently added as patient code.There was no consequences or impact to the patient involved.Section h10: the lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for the evaluation.The training records for the manufacturing associates involved in the event indicate they were up to date with all training pertinent to the manufacture of this product.Also there was no indication of maintenance documented in the maintenance log for the dates of production for this affected lot.As part of continuous improvements, a corrective action has been opened.The capa is currently in the investigation stage.This lot falls within the scope of the capa.A quality alert was issued to address containment notification to the operators in the vistec room.There was a quality stand down with the operators, and heightened quality inspection has also been implemented with an emphasis on miscounts.Brainstorming activities took place with area supervisor, quality engineer, area mechanic, and manufacturing associate.Gemba activities took place to walk through process flow and identify areas where the issue could have occurred.

• Brand Name: 7462 VISTEC SPG 8X4 12P T-10'S
• 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: 10396441
• Report Number: 1018120-2020-00420
• Device Sequence Number: 16826239
• Product Code: GDY
• UDI-Device Identifier: 10884527017065
• UDI-Public: 10884527017065
• 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): 10/08/2020

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: 7462
• Device Catalogue Number: 7462
• Device Lot Number: 19H020462
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/10/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 10/08/2020
• Patient Sequence Number: 1