MAUDE Adverse Event Report: BECTON DICKINSON BD ORGANON FOLLISTIM PEN 2ND GEN PEN II; PEN NEEDLE

Catalog Number 47338178

Device Problems Misconnection (1399); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4) has been listed as merck is an oem manufacturing site.Medical device expiration date: n/a.Initial reporter phone #: 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 the pen was not functioning correctly and medication was not being delivered appropriately with a bd organon follistim pen 2nd gen pen ii.The following information was provided by the initial reporter: consumer reported she received a new follistim pen and a 900 iu cartridge, she dispensed her dose 150 iu for 6 days and the follistim cartridge should have been empty after 6 days, but after the sixth day, the cartridge was 1/2 to 2/3 full.

Event Description

It was reported that the pen was not functioning correctly and medication was not being delivered appropriately with a bd organon follistim pen 2nd gen pen ii.The following information was provided by the initial reporter: consumer reported she received a new follistim pen and a 900 iu cartridge, she dispensed her dose 150 iu for 6 days and the follistim cartridge should have been empty after 6 days, but after the sixth day, the cartridge was 1/2 to 2/3 full.

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 batch involved in this complaint meets all acceptable quality levels (aql¿s), was 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.Based on investigation conclusion, bdm-ps was not able to confirm the symptom perceived by customer or correlate this symptom with a potential cause linked to bd process.H3 other text : see h.10.

• Brand Name: BD ORGANON FOLLISTIM PEN 2ND GEN PEN II
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8965799
• MDR Text Key: 156773750
• Report Number: 2243072-2019-01915
• 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: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 47338178
• Device Lot Number: 18281008
• Date Manufacturer Received: 08/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other