MAUDE Adverse Event Report: COOPERSURGICAL, INC. BSC SKW SYSTEM

Model Number 72403867

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.Once the investigation process is completed a follow-up report will be filed.(b)(4).

Event Description

Lot 9266702307 carton was sent to a customer; the customer returned an inventory tracking form containing the pouch peel-off label for lot 9266702306; the 9266702306 carton was not shipped to this customer.(b)(4).

Event Description

Lot 9266702307 carton was sent to a customer; the customer returned an inventory tracking form containing the pouch peel-off label for lot 9266702306; the 9266702306 carton was not shipped to this customer.Ref: (b)(4).

Manufacturer Narrative

Reference: (b)(4).Investigation: x-initiated manufacturer's investigation.X-review dhr.Analysis and findings: dhr review of product no.72403867, ams wilson kit, serial no.(b)(6) /lot 2666702 manufacture date of feb 2019 shows all products were manufactured and tested per established procedures at csi stafford facility.The images provided shows the outer box serial number and in inner pouch serial number being mismatched with that of the subsequent, numerical serial number ((b)(6)).Both the pouch label and outer box labels are pre-printed at the beginning of the work order.The pouches are first labeled, and then boxed into the outer box at final packaging.The final process is to place the label outside of the box.Currently, there is an effort to implement barcode scanner that will scan each pouch label in order to print the outer box label individually, prior to it being affixed on the outer box.In doing so, each individual box label will be printed as the pouched units are received.2 year complaint history shows other lots to be affected, and complaint were logged at the same time as the current one.Correction and/or corrective action: to address issue with mismatched serial numbers, the csi stafford facility is currently working on implementing a system to individually print the outer box labels after scanning of the pouch labels, to prevent a mismatch.A quality alert, qa-00151 was created to alert issue with final packaging.The efforts to implement the barcode scan to print process will be documented under an event report ((b)(4)).This complaint will be monitored for trending.Was the complaint confirmed? yes.

• Brand Name: BSC SKW SYSTEM
• Type of Device: BSC SKW SYSTEM
• Manufacturer (Section D): COOPERSURGICAL, INC.; 95 corporate drive; trumbull CT 06611
• MDR Report Key: 8640952
• MDR Text Key: 146343968
• Report Number: 1216677-2019-00092
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• PMA/PMN Number: K791665
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/26/2024
• Device Model Number: 72403867
• Device Catalogue Number: 72403867
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other