Catalog Number 47264778 |
Device Problem
Mechanical Problem (1384)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 04/30/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Date of event: unknown.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 operation difficulty occurred with a pen ii omnitrope pen 5 1.5ml.The following information was provided by the initial reporter, "high resistance: "rapporteur reported that her pen is locking 2 days ago and she can not applying the full dosage, so she needs to pierce 2 times.Not tested with another ampoule.".
|
|
Manufacturer Narrative
|
H.6.Investigation: one (1) sample was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections.The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications.Initial evaluation revealed no visible damage to the pen.The sample was tested for functionality through dose set knob (dsk) push force test (test instruction it1182) and by performing sample injections.The returned complaint pen met dsk push force test specification.The pen functioned as intended during the sample injections.Unconfirmed, no issue observed.
|
|
Event Description
|
It was reported that operation difficulty occurred with a pen ii omnitrope pen 5 1.5ml.The following information was provided by the initial reporter, "high resistance: "rapporteur reported that her pen is locking 2 days ago and she can not applying the full dosage, so she needs to pierce 2 times.Not tested with another ampoule.".
|
|
Search Alerts/Recalls
|