MAUDE Adverse Event Report: COVIDIEN 7318 SPG VISTEC 8 X 4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7318

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the x-ray detectable thread came out of the gauze sponge.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Few samples were received for the evaluation.Upon visual evaluation, all the sponges had radiopaque element adhered to the sponges.However, there was a piece of element that was loose from the rest of the sponges.Therefore, the reported condition is confirmed.The possible root cause could be during the element application process if when the element traverses around the pressure roller, heated roller, and bonding wheel that the element does not adhere properly, then the element can have the opportunity to become loose within the folds of the sponge.However, with the way the sponges are folded reduces the chance of the element from falling out throughout a procedure.Another possible root cause could be that during this process the element could have burnt in pieces and was caught between the sponges.The sample sponge will be sent to the production for quality awareness.As a preventive action, if the element has been in pieces, the sensors on the machine will shut down the machine, until the issue has been fixed and the defective sponges before the machine shutdown will be inspected.Regular inspections are performed based on the statistical sampling both physically and visually.Specifically, operators are required to inspect the samples at the beginning, middle and end of the lot production.These checks are noted on the device history record.

• Brand Name: 7318 SPG VISTEC 8 X 4 STR 10'S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• MDR Report Key: 9570088
• MDR Text Key: 174364796
• Report Number: 1018120-2020-00396
• Device Sequence Number: 1
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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
• Device Operator: No Information
• Device Model Number: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 19J029262
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Manufacturer Received: 01/02/2020
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/02/2020
• Supplement Dates FDA Received: 01/29/2020
• Patient Sequence Number: 1