Catalog Number 0250080618 |
Device Problem
Device Packaging Compromised (2916)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 03/22/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Additional information will be provided once the investigation has been completed.The device manufacture date is not known at this time.However, should it become available it will be provided in future reports.(b)(4).
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Manufacturer Narrative
|
Alleged failure: lot 1641521h cracked cib melanie purchasing po#: (b)(4).The failure(s) identified in the investigation is consistent with the complaint record.The probable root cause/s could improper cleaning or sterilization normal wear.The product was returned for investigation and the failure mode will be monitored for future reoccurrence.
|
|
Event Description
|
It was reported that the insulation had been compromised.
|
|
Search Alerts/Recalls
|