MAUDE Adverse Event Report: COVIDIEN 7317 SPG VISTEC 4X4 STR 10'S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7317

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 04/16/2019

Event Type  malfunction  

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 Description

Customer reports that the radiopaque blue strip is not staying in tact to the sponge and falling apart.They opened a few different packages and the issue varies from each package with some being minor to others being unusable.The packages that were opened were not used on a patient.They were removed beforehand.

• Brand Name: 7317 SPG VISTEC 4X4 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
• 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: 8544938
• MDR Text Key: 142931058
• Report Number: 1018120-2019-00356
• Device Sequence Number: 1
• Product Code: GDY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2019

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: 7317
• Device Catalogue Number: 7317
• Device Lot Number: 18J019862
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 04/16/2019
• Initial Date FDA Received: 04/24/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1