Catalog Number 305945 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E.4.Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4).H.3.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 needle fell off the bd safetyglide¿ tuberculin syringe when attempting to engage the needle cap during use.The following information was provided by the initial reporter: "describe the event or problem: after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.".
|
|
Event Description
|
Mat# 305945.Lot# 2221003a1.It was reported by the customer that after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.(b)(4).Lot# 2221003a1 (not able to find in sap) event title: no event title provided describe the event or problem: after injection, the registered nurse went to engage the needle cap cover with her index finger and as she pushed the cover device fell off (complete disconnection from syringe).No harm to staff or patient.What problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do; additional info received on 31mar2023 were you able to correct the issue using another needle? based on information known at this time, the medication had already been administered and the protective cap fell off when the nurse attempted to engage the device.No other device was needed.
|
|
Manufacturer Narrative
|
Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
|
|
Search Alerts/Recalls
|