Catalog Number 8065797303 |
Device Problem
Filling Problem (1233)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 01/14/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
No sample has been received by manufacturing for evaluation.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
|
|
Event Description
|
A health professional reported that an ophthalmic gas dispensing regulator would not fill a syringe after attempting the use for five minutes.Procedure details, patient involvement and patient impact information is unknown.Additional information received clarified that the ophthalmic gas dispensing regulator would not dispense gas prior to the start of a vitrectomy surgery.An alternate gas was obtained in order to proceed with the scheduled procedure.There was no patient involvement or patient impact associated with the reported event.
|
|
Manufacturer Narrative
|
The customer's regulator was not returned for evaluation however, the contract manufacturer was notified of this report.The contract manufacturer's investigation results have not yet been received to date.A review of complaints for the last 12 months did indicate four additional related reports for this regulator.With no additional, related information provided, the customer reported event could not be confirmed.The root cause of the reported event cannot be determined conclusively.Data will continue to be monitored for evidence of adverse trending with further action taken, as appropriate.The manufacturer internal reference number is: (b)(4).
|
|
Manufacturer Narrative
|
Per the contract manufacturer evaluation, one ophthalmic gas regulator from the reported lot number was received for evaluation.The regulator was in good condition as received and was put through final inspection tests.The regulator passed all release criteria.The regulator was tested multiple times on two different days with the same result.The customer reported event could not be confirmed or replicated.A review of the batch production record for the reported lot was performed and confirmed that the product met specifications at the time of release.A review of the complaint records showed eight other complaints against the reported lot number since release.The returned regulator was found to meet specifications therefore, the customer reported event could not be confirmed nor replicated and root cause could not be determined.The manufacturer internal reference number is: (b)(4).
|
|
Search Alerts/Recalls
|