MAUDE Adverse Event Report: COVIDIEN NSSA; OR SPONGES

Model Number SA2230A

Device Problems Incomplete or Missing Packaging (2312); Packaging Problem (3007)

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

Event Date 07/24/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with or sponges.The customer reports that when the kit was opened it contained 4 lap sponges instead of 5.They reported the miscount and replaced it with sterile items.

Manufacturer Narrative

Submit date: (b)(6) 2016.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 reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.There were no samples submitted with this complaint therefore the reported condition could not be confirmed.The complaint shall be reopened if a sample is received.The kit code (b)(4) includes the lap sponge part number (b)(4).These lap sponges are not manufactured by the covidien plant and during the receiving inspection process, there were no issues detected.Additionally, a certificate of analysis is provided by the vendor to ensure that the kit components meet the specification required.During the kit assembly process according to the procedure the visual aid notes that the lap sponge process is a (b)(4) operation.There is no additional inspection on the line to detect the condition reported.The most likely root cause is that the material was not received in accordance to the specification.As an immediate containment, the personnel involved in the process were notified of the issue to heighten awareness about this reported condition.The inspection level at the manufacturing line was increased from normal to elevated.A quality alert was posted in at the incoming inspection area, the manufacturing line and the qa laboratory.As a corrective action, the raw material will be weighed at the production line to confirm that the correct quantity is included in the kits.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: NSSA
• Type of Device: OR SPONGES
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana 22500 ; MX 22500
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5147397
• MDR Text Key: 28652602
• Report Number: 9612030-2015-00095
• 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: 10/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SA2230A
• Device Catalogue Number: SA2230A
• Device Lot Number: 4317100064X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1