PERITONEAL INTRODUCER SHEATHS 70CM
Received Sep 29, 2016 · Event occurred Jul 28, 2016
Report 9612007-2016-00038 · MDR key 5988769
Device
Generic name
Valve Accessories
Manufacturer
Integra Neuroscicencs Implants SaCatalog number
9MD170
Lot number
0195056
Product problems
- Bent
- Break
- Device Packaging Compromised
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Description of Event or Problem
PACKAGE WAS RECEIVED INTACT BUT WHEN IT WAS OPENED, THE PRODUCT PACKAGING WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY. ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER ON 09AUG2016: THE PRODUCT PROBLEM WAS DISCOVERED WHEN IT WAS DELIVERED. THE BOX THAT HOLDS THE PRODUCT WAS BENT IN AND DAMAGED.
Additional Manufacturer Narrative
INTEGRA COMPLETED ITS INTERNAL INVESTIGATION 14NOV2016. THE INVESTIGATION INCLUDED: METHOD: - REVIEW OF DEVICE HISTORY RECORDS. - REVIEW OF COMPLAINT MANAGEMENT DATABASE FOR SIMILAR COMPLAINTS. RESULTS: THE DEVICE HISTORY RECORDS OF REF 9MD170 LOT 195056 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY. THE BATCH WAS MANUFACTURED IN APRIL 2016 AND INCLUDED (B)(4) PRODUCTS. NO SIMILAR COMPLAINT WAS RECEIVED FOR A PRODUCT FROM THIS BATCH. THE REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE SINCE 2013 FOR 9MD170 REVEALED NO SIMILAR COMPLAINT. (B)(4). A REVIEW OF INTEGRA COMPLAINT TRACKING DATABASE FOR ALL OTHER BIOT PRODUCTS SINCE 2013 REVEALED TWO SIMILAR SHIPPING ISSUES. CONCLUSION: NO PRODUCT WAS RECEIVED; THE COMPLAINT IS UNVERIFIABLE. THE MOST LIKELY CAUSE IS A DAMAGE DURING THE SHIPMENT TO THE HOSPITAL.