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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON ORGANON FOLLISTIM PEN 2ND GEN PEN II; INSULIN PEN
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BECTON DICKINSON ORGANON FOLLISTIM PEN 2ND GEN PEN II; INSULIN PEN Back to Search Results
Catalog Number 47338178
Device Problems Use of Device Problem (1670); Failure to Deliver (2338)
Patient Problem Underdose (2542)
Event Date 04/23/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.(b)(4).
 
Event Description
It was reported that the organon follistim pen 2nd gen pen ii experienced an inability to deliver medication during injection.The following information was provided by the initial reporter: reported that she didn't realize that her cartridges were 300iu, she used only 1 cartridge.Did not realize that she did not get th dose she was suppose to take the pen allowed her to dial to 374iu despite not having enough meds in the cartridge.Pharmacist confirms this to be user error, patient did not realize she was using a 300 iu cartridge, when her dose was actually 375iu.
 
Event Description
It was reported that the organon follistim pen 2nd gen pen ii experienced an inability to deliver medication during injection.The following information was provided by the initial reporter: reported that she didn't realize that her cartridges were 300iu, she used only 1 cartridge.Did not realize that she did not get th dose she was suppose to take the pen allowed her to dial to 374iu despite not having enough meds in the cartridge.Pharmacist confirms this to be user error, patient did not realize she was using a 300 iu cartridge, when her dose was actually 375iu.
 
Manufacturer Narrative
H.6.Investigation: zero (0) samples were provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis.Bdm-ps could not perform a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections since the batch number is unknown.Since the sample was not received and the lot history is unknown, investigation cannot be performed as a sample is required to investigate further.
 
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Brand Name
ORGANON FOLLISTIM PEN 2ND GEN PEN II
Type of Device
INSULIN PEN
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8595256
MDR Text Key148429700
Report Number2243072-2019-00886
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 distributor,other
Type of Report Initial,Followup
Report Date 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number47338178
Device Lot NumberUNKNOWN
Date Manufacturer Received04/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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