MAUDE Adverse Event Report: BECTON DICKINSON PEN II ORGANON PUREGON® PEN SECOND GEN; PEN NEEDLE

Catalog Number 47289378

Device Problem Inaccurate Delivery (2339)

Patient Problem Underdose (2542)

Event Date 06/06/2018

Event Type  Injury  

Manufacturer Narrative

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.Therefore, bd corporate headquarters in (b)(4) has been listed in sections and the (b)(4) fda registration number has been used for the manufacture report number.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 after the patient had completed six doses of "follitropin beta" with the pen ii organon puregon® pen second gen, the pen injector "still had 2/3rds of the medication in it (underdose)".The patient "did not respond to the drug and failed their cycle", but it was reported that "the outcome of the event was unknown", and "the casualty was not provided".

Event Description

It was reported that after the patient had completed six doses of "follitropin beta" with the pen ii organon puregon® pen second gen, the pen injector "still had 2/3rds of the medication in it (underdose)".The patient "did not respond to the drug and failed their cycle", but it was reported that "the outcome of the event was unknown", and "the casualty was not provided".

Manufacturer Narrative

Investigation summary: zero (0) samples were 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.Since the sample was not received, investigation cannot be performed as a sample is required to investigate further.

• Brand Name: PEN II ORGANON PUREGON® PEN SECOND GEN
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8199488
• MDR Text Key: 131503379
• Report Number: 2243072-2018-01912
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47289378
• Device Lot Number: 15120006
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR