MAUDE Adverse Event Report: COOPERSURGICAL, INC. THIN PREP PAP 500 TSTS/CS

Model Number 02500

Device Problem Scratched Material (3020)

Patient Problems Bruise/Contusion (1754); Hemorrhage/Bleeding (1888)

Event Date 02/03/2016

Event Type  malfunction  

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.(b)(4).

Event Description

"end user complains that bag of spatulas has some sharp plastic around collection type that the edges that are sharp and cutting patients and causing bleeding.There are a least a few spatulas in all bags according to customer.The end user would not like replacements.They just want the spatulas to all be the same without sharp edges." (b)(4).

Manufacturer Narrative

Coopersurgical inc.Is currently investigating the reported complaint condition.The device involved in the complaint has not been returned by the customer for evaluation.Once the investigation is completed a follow-up report will be filed.Reference e-complaint: (b)(4).Folow up investigation x-initiated manufacturer's investigation x-no sample returned x-review dhr inspect returned samples x-inspect stock product analysis and findings an evaluation of the complainant samples could not be conducted since they will not be returned.The plastic spatulas, part number 11080b, are molded at coopersurgical.The spatulas are placed into a bag with brushes and the ifu.The 20 bags are placed into a box which is shipped to the customer.A review of the dhr did not find any abnormalities.A sampling of spatulas stock inventory were taken and in some cases, flash was found at the distal end of the part.This was traced back to lot numbers 171854 and 171855 only.Non-conforming material report (ncmr) 2653 was issued to document the non-conformity.Correction and/or corrective action all stock inventory of lot numbers 171854 and 171855 were scrapped.Changed the nozzle tips in each cavity to better control the amount of material in the mold.Quality alert qa-00012 was issued and placed at the molding station and the packing station.Appropriate personnel were trained to the quality alert.Corrective action level 2 x-train personnel was the complaint confirmed? yes review and closure x-recommended continuous improvement program (cip) capa required? complaint closure letter required? ncmr issued? other regulatory action needed: *preventative action activity reviewed.Trend and monitor to cip.

Event Description

"end user complains that bag of spatulas has some sharp plastic around collection type that the edges that are sharp and cutting patients and causing bleeding.There are a least a few spatulas in all bags according to customer.The end user would not like replacements.They just want the spatulas to all be the same without sharp edges." reference e-complaint number : (b)(4).

• Brand Name: THIN PREP PAP 500 TSTS/CS
• Type of Device: THIN PREP PAP 500 TSTS/CS
• Manufacturer (Section D): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer (Section G): COOPERSURGICAL, INC.; 75 corporate drive; trumbull CT 06611
• Manufacturer Contact: nana banafo ; 75 corporate drive; trumbull, CT 06611 ; 2036015200
• MDR Report Key: 5614229
• MDR Text Key: 44667731
• Report Number: 1216677-2016-00007
• Device Sequence Number: 1
• Product Code: OHL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

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: Physician
• Device Model Number: 02500
• Device Catalogue Number: 02500
• Device Lot Number: 168875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2016
• Initial Date FDA Received: 04/28/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1