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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON PEN II OMNITROPE PEN 10; PEN NEEDLE
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BECTON DICKINSON PEN II OMNITROPE PEN 10; PEN NEEDLE Back to Search Results
Catalog Number 47286578
Device Problem Leak/Splash (1354)
Patient Problem Underdose (2542)
Event Date 05/15/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that pen ii omnitrope pen 10 leaked.The following information was provided by the initial reporter: dripping pen.Mother of patient called in to report that the new pen she received from omni source is leaking.She stated having the same issue as last time with it leaking and not sure if her child it getting enough medication.With the leaking pen she said they are running short on medication.Stated it is dripping drops, not a steady stream.
 
Event Description
It was reported that pen ii omnitrope pen 10 leaked.The following information was provided by the initial reporter: dripping pen.Mother of patient called in to report that the new pen she received from omni source is leaking.She stated having the same issue as last time with it leaking and not sure if her child it getting enough medication.With the leaking pen she said they are running short on medication.Stated it is dripping drops, not a steady stream.
 
Manufacturer Narrative
Investigation summary: 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 batch involved in this complaint meets all acceptable quality levels (aql¿s), was manufactured and released according to applicable procedures and specifications.Initial evaluation of the returned complaint sample revealed no visible damage to the pen.An injection sequence was executed using a 31g x 5mm bd pen needle and placebo cartridge.The pen was evaluated for leaking from the needle by observing the number of droplets that formed 30 seconds after needle attachment and after administering low dose, mid dose, and high dose injections.For each injection, the 30 second allowance began after a 5 second hold time at the end of injection.Investigator observed droplets forming at the needle tip during the 30 second allowance.The number of droplets observed was as follows: after needle attachment after low dose after mid dose after high dose droplets observed (pen 1) 8 2 1 3 based on investigation conclusion, bdm-ps was able to confirm the detection and characterize the condition reported by customer.The reported condition has been confirmed but is not defined in the applicable specification.As a consequence, bdm-ps will not conduct a full root cause analysis.However this complaint is registered in bd complaint system and trend analysis will be performed.
 
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Brand Name
PEN II OMNITROPE PEN 10
Type of Device
PEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8654821
MDR Text Key146682110
Report Number2243072-2019-01043
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/20/2019
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 Date10/09/2021
Device Catalogue Number47286578
Device Lot Number18263003
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2019
Initial Date Manufacturer Received 05/15/2019
Initial Date FDA Received05/30/2019
Supplement Dates Manufacturer Received05/15/2019
Supplement Dates FDA Received06/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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