NOZZLE,STRAIGHT,ABC,DISP/20
Received Jan 3, 2018
Report 3007305485-2017-00293 · MDR key 7159682
Device
Generic name
Abc Handpieces-open
Manufacturer
Consolidated Medical EquipmentCatalog number
130343
Lot number
201703294
Product problems
- Packaging Problem
- Packaging Problem
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE REPORTED DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED UPON THE COMPLETION OF THE PRODUCT EVALUATION AND COMPLAINT INVESTIGATION.
Description of Event or Problem
THE DISTRIBUTOR IN (B)(4) REJECTED 30 ABC NOZZLES FOR "INSUFFICIENT HEATSEAL" DURING INCOMING INSPECTION. IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THE REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY WITH RECURRENCE.
Additional Manufacturer Narrative
THIS INCIDENT WAS DISCOVERED TO BE A DUPLICATE OF THE INCIDENT REPORTED ON COMPLAINT (B)(4), MDR 3007305485-2017-00233.