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

Model Number 7148

Device Problem Incomplete or Missing Packaging (2312)

Patient Problem No Information (3190)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer states: the package only contained 9 sponges.

Manufacturer Narrative

The device history record (dhr) for lot number 18f127462 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.A capa is currently open to investigate the reported issue.The reported customer complaint could not be confirmed.A root cause could not be determined.A formal capa investigation is currently in progress.This complaint will be utilized for tracking and trending purposes.

• Brand Name: 7148 VISTEC SPG 4X4 16P T-10S
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8170516
• MDR Text Key: 130620114
• Report Number: 1018120-2018-00319
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7148
• Device Catalogue Number: 7148
• Device Lot Number: 18F127462
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1