MAUDE Adverse Event Report: COVIDIEN DERMACEA; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 441601

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Submit date: 04/10/2017.An investigation is currently underway.Upon completion,the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reported that strings of the gauze were coming off of the gauze during surgery.Due to this the surgeon had to flush the wound to get the strings and particles out that were left behind.

Manufacturer Narrative

The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were samples returned for investigation.One photograph has been received from the customer.Based on the photograph small pieces of the strings in the edge of the gauze could be observed.According to the investigation with limited information, the possible root cause may have occurred during the manufacturing warehouse if the cutting blade moved during the cutting process causing the gauze to pulverize resulting in loose contamination.The supplier has taken following actions: changed the swabs design of below gauze layer to increase 1-1.5cm width in first folding and below gauze must be use one side edge fold swabs to prevent lint contamination; added a cleaning process after cutting; changed the slitting device and adopt automatic slitting machine that improve slitting accuracy to prevent sponges are flaking.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: DERMACEA
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6476878
• MDR Text Key: 72259077
• Report Number: 1282497-2017-05082
• 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: 12/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 441601
• Device Catalogue Number: 441601
• Device Lot Number: 17051204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2017
• Initial Date FDA Received: 04/10/2017
• Supplement Dates Manufacturer Received: 03/23/2017
• Supplement Dates FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention