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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON PEN II OMNITROPE PEN 5 1.5ML; INJECTOR PEN

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BECTON DICKINSON PEN II OMNITROPE PEN 5 1.5ML; INJECTOR PEN Back to Search Results
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.".
 
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Brand Name
PEN II OMNITROPE PEN 5 1.5ML
Type of Device
INJECTOR PEN
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8617575
MDR Text Key145503866
Report Number2243072-2019-00945
Device Sequence Number1
Product Code NSC
UDI-Device Identifier00382904726478
UDI-Public382904726478
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date03/22/2021
Device Catalogue Number47264778
Device Lot Number17062002
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2019
Initial Date Manufacturer Received 04/30/2019
Initial Date FDA Received05/16/2019
Supplement Dates Manufacturer Received04/30/2019
Supplement Dates FDA Received06/03/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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