Catalog Number 324827 |
Device Problem
Break (1069)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/10/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that syringe 1ml 29g 12.7mm 10bag 500 eu cannula broke.The following information was provided by the initial reporter: a customer has complained that the needle is missing from some syringes or that the needle sometimes remains in the body after the injection.
|
|
Manufacturer Narrative
|
Date of event: unknown.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
It was reported that syringe 1ml 29g 12.7mm 10bag 500 eu cannula broke.The following information was provided by the initial reporter: a customer has complained that the needle is missing from some syringes or that the needle sometimes remains in the body after the injection.
|
|
Manufacturer Narrative
|
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-10-21.H6: investigation summary customer returned (2) loose 1cc syringes.Customer states that the needle sometimes remains in the body after the injection.Both returned syringes were examined and both exhibited a broken barrel without the cannula.Unable to perform dhr check for needle breaks off during use due to unknown lot number.Bd was able to duplicate or confirm the customer¿s indicated failure a broken barrel without the cannula.No root cause can be determined.H3 other text : see h10.
|
|
Search Alerts/Recalls
|