MAUDE Adverse Event Report: COVIDIEN 7148 VISTEC SPG 4X4 16P T-10S; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 7148

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2018

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states that the gauze is falling apart.

Manufacturer Narrative

Added the lot number 18a068262 to medical device.A device history record review was completed for lot# 18a068262.There were no manufacturing related issues related to the complaint issued for this lot.10 sponge samples were received for evaluation.After visually examination and cross examining the sponges, the complaint will be confirmed for raw edges.The returned product did not meet quality release specifications for raw edges.The reason for the raw edges in the product is due to unfolded cut edges of the gauze that will protrude through the folds or edges of the folds which may mean that the sponge has come unfolded, causing the cut edges to become visible outside of the sponge.Physical sample was taken to the department and a quality impact was discussed.Complaint trending information is being reviewed on a routine basis and if a trend is observed, actions will be taken as necessary.This information will be utilized for tracking and trending purposes.Samples were received and analyzed.

• Brand Name: 7148 VISTEC SPG 4X4 16P T-10S
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire st; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8156933
• MDR Text Key: 130186395
• Report Number: 1282497-2018-08202
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2019

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: Health Professional
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 18A068262
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1