MAUDE Adverse Event Report: INTEGRA LIFESCIENCES CORPORATION OH/USA CRW BIOPSY PLUS; N/A

Catalog Number CRWBP

Device Problems Product Quality Problem (1506); Difficult to Open or Remove Packaging Material (2922)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Investigation was completed 7/31/2017.The dhr for w1504055 was reviewed and no ncmr or other issue was found related to this complaint failure mode.The kit lot was assembled in august 2015.A two year look back in the complaint system from 06/22/2015 to 06/22/2017 for the reported failure and or related to "packaging" for this product family (crwbp) shows that two additional complaints were received.No new design or manufacturing trends have been identified.A complaint investigation (failure analysis) and determination of root cause was not possible as the complaint could not be verified due to a product sample was not returned in order to verify the complaint.

Event Description

When opening the kit, the peel pouch cover was sticking to the sterile container that needed to be dropped into the sterile field.They couldn¿t get the outer and inner packages to separate.There was no patient contact, injury or any delay in surgery.

Manufacturer Narrative

Investigation completed 10/09/2017.The dhr for w1504055 was reviewed and no ncmr or other issue was found related to this complaint failure mode.The kit lot was assembled in august 2015.A two year look back from 06/22/2015 to 06/22/2017 for this reported failure and or related to "packaging" for this product family (crwbp) shows no new design or manufacturing trends have been identified.The returned product showed that the inner tray tyvek lid was incidentally sealed between the outer tray and outer tyvek lid causing the inner lid to partially adhere to the outer lid.The process of sealing the inner tray between the outer tray and lid causes the inner lid to be damaged when opening the outer tray/lid.The root cause for the packaging failure on the returned product was that the inner lid was sealed between the outer tray and lid during the sealing process.The inner tray is designed to fit into the outer tray and not come in contact with the outer tray seal, however, the inner lid has excess material that is capable of falling into the seal area of the outer tray and lid.The outer tray is designed to indicate a specific corner as being the location for opening tray, due to the tray being trimmed shorter on the corner allowing a small portion of lid to be exposed.The exposed outer lid design allows the user to easily grasp the lid to open the kit.After reviewing the sealing process, it was determined that by tucking the corner of the inner lid into the outer tray prior to sealing it is possible to effectively prevent reoccurrence of the inner lid being sealed between the outer lid and outer tray.The crwbp master specifications will be updated to require the operator to seal the product using this method for all future orders.

• Brand Name: CRW BIOPSY PLUS
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer (Section G): INTEGRA LIFESCIENCES CORPORATION OH/USA; 4900 charlemar drive; cincinnati OH 45227
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6793120
• MDR Text Key: 82939810
• Report Number: 3004608878-2017-00243
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• PMA/PMN Number: K944463
• 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: 05/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CRWBP
• Device Lot Number: W1504055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1