Catalog Number 307736 |
Device Problem
Packaging Problem (3007)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/03/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.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 195 bd emerald¿ syringes were found with damaged packaging/open seals.The following information was provided by the initial reporter, translated from (b)(6) to english: "we found 10 pieces / 195 pieces with packaging open.Sealing is open.".
|
|
Event Description
|
It was reported that 195 bd emerald¿ syringes were found with damaged packaging/open seals.The following information was provided by the initial reporter, translated from german to english: "we found 10 pieces / 195 pieces with packaging open.Sealing is open.".
|
|
Manufacturer Narrative
|
The following fields were updated due to corrected information: d.10.Device available for eval?: no.D.10.Returned to manufacturer on: na.H.6.Investigation: a device history record review was performed for provided lot number 2005269.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, a picture sample was returned for evaluation by our quality engineer team.Through examination of the picture, the blister packages were observed open.It has been determined that the blisters were open on one side of the packaging due to a misalignment during the blister cutting process.The cutting of the blisters should be performed correctly to keep the sealed area of each unit intact.In this case, the cutting was misaligned and the sealed area was not kept.
|
|
Search Alerts/Recalls
|