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

Model Number	7318
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 particles in the gauze and the fibers of the gauze break down.There was no harm to the patient.
Additional Manufacturer Narrative
Correction: e 1 the initial reporter address was corrected per additional information received.
Additional Manufacturer Narrative
H3 evaluation summary a review of the device history record (dhr) for the reported lot indicates no acceptable quality level (aql) failures.No manufacturing or inspection anomalies were found.All verifications and reviews were performed and documented in the dhr.Prior to a lot¿s release, the lots must be deemed acceptable.Inspectors routinely examine a statistical sample both physically and visually.The reported lot met all defined acceptance requirements and was released.One opened tray was returned for investigation.Upon opening the sample, the sponges appear to have been removed and placed back into the tray.There are ten (10) sponges in the tray.Based on the visual evaluation, the reported issues of fraying and falling apart are not confirmed since the returned samples in the tray do not exhibit these conditions.However, there is a large brown particle on the top sponge that visually resembles a piece of corrugate.Per a previous investigation for contamination and value stream mapping identification there were multiple causes identified for contamination including housekeeping and machine cleaning processes.A corrective and preventative action (capa) was initiated to address the contamination.Changes were made to the vistec cleaning procedure and personnel were trained to the new procedure.Housekeeping and cleaning procedures were updated and implemented.The machine cleaning procedures were also updated and implemented.A new oiler system was installed on the line.The corrective actions were implemented after the reported lot number was released therefore no further action is needed at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 7318 SPG VISTEC 8 X 4 STR 10'S
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road, po b; augusta GA 30906
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11725777
• Report Number: 1018120-2021-00443
• Device Sequence Number: 19692284
• Product Code: GDY
• UDI-Device Identifier: 00884527017006
• UDI-Public: 00884527017006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2021

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 Model Number: 7318
• Device Catalogue Number: 7318
• Device Lot Number: 19K027062
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 04/15/2021; 04/15/2021
• Initial Report FDA Received Date: 04/26/2021
• Supplement Report FDA Received Date: 05/07/2021; 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown