Catalog Number 38732614 |
Device Problems
Device Damaged Prior to Use (2284); Structural Problem (2506)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 03/21/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that the saf-t ezset bl standard 25ga.75in ndl adapter was found damaged after removing it from the packaging, and would not connect to the syringe.The following information was provided by the initial reporter, translated from (b)(6) to english: "when opening the packaging of the device to perform collection, it was noticed that the adapter was bowed not allowing connection with the syringe.".
|
|
Manufacturer Narrative
|
Investigation: our quality engineer was unable to verify the reported complaint.Photos or samples are not available for analysis and because no objective evidence of this issue was found during the analysis of the device history record and quality notifications for the claimed lot, it was not possible to verify this complaint as being generated by manufacturing process.
|
|
Event Description
|
It was reported that the saf-t ezset bl standard 25ga.75in ndl adapter was found damaged after removing it from the packaging, and would not connect to the syringe.The following information was provided by the initial reporter, translated from portuguese to english: "when opening the packaging of the device to perform collection, it was noticed that the adapter was bowed not allowing connection with the syringe.".
|
|
Search Alerts/Recalls
|