Catalog Number 328325 |
Device Problem
Failure to Deliver (2338)
|
Patient Problem
Hypersensitivity/Allergic reaction (1907)
|
Event Date 03/22/2021 |
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 bd ultra-fine¿ ii insulin syringe plunger became "stuck" during use.The following information was provided by the initial reporter, translated from portuguese to english: "patient informs that felt pain to apply growth hormone.Felt the needle "grabbing" to skin, rough.The plunger is stuck, and needle is dull.Muscle became stiff like a lump.Reports that performs the applying local rotation and does not reuse the needles.".
|
|
Manufacturer Narrative
|
H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.A review of the device history record was completed for batch# 9308326.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.H3 other text : see h10.
|
|
Event Description
|
It was reported that the bd ultra-fine¿ ii insulin syringe plunger became "stuck" during use.The following information was provided by the initial reporter, translated from portuguese to english: "patient informs that felt pain to apply growth hormone.Felt the needle "grabbing" to skin, rough.The plunger is stuck, and needle is dull.Muscle became stiff like a lump.Reports that performs the applying local rotation and does not reuse the needles.".
|
|
Search Alerts/Recalls
|