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

Catalog Number 47289378

Device Problems Use of Device Problem (1670); Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/21/2019

Event Type  malfunction  

Manufacturer Narrative

For oem manufacturing sites: in this mdr, bd corporate headquarters in (b)(4).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 with a bd pen ii organon puregon pen second gen.The following information was provided by the initial reporter: the client informs that his wife is undergoing treatment.She reports that she used the drug for the first time now in (b)(6) (she could not tell the exact date) and reports that the doctor prescribed 75 units to use for 5 days the first time and reported that using a 300 ampoule units with this amount of 75 units for 5 days was still left over and on the last day of treatment she made use of the rest of the medicine that was still in the ampoule.And the second time the patient took medication, the doctor prescribed 150 units of 3 days, reports that you purchased one ampoule of the drug and the clinic sold another already opened ampoule of 300 units containing only 150 units to give the exact amount to be used for 3 days, but the rapporteur reported that in only 1 ampoule of 300 units the patient performed the treatment for the 3 days and there remained about 10 millimeters more to the other ampoule that was in half.The rapporteur said that the patient knows how to use the medicine and believes that the pen is malfunction.

Event Description

It was reported that the pen was not functioning with a bd pen ii organon puregon pen second gen.The following information was provided by the initial reporter: the client informs that his wife is undergoing treatment.She reports that she used the drug for the first time now in march (she could not tell the exact date) and reports that the doctor prescribed 75 units to use for 5 days the first time and reported that using a 300 ampoule units with this amount of 75 units for 5 days was still left over and on the last day of treatment she made use of the rest of the medicine that was still in the ampoule.And the second time the patient took medication, the doctor prescribed 150 units of 3 days, reports that you purchased one ampoule of the drug and the clinic sold another already opened ampoule of 300 units containing only 150 units to give the exact amount to be used for 3 days, but the rapporteur reported that in only 1 ampoule of 300 units the patient performed the treatment for the 3 days and there remained about 10 millimeters more to the other ampoule that was in half.The rapporteur said that the patient knows how to use the medicine and believes that the pen is malfunction.

Manufacturer Narrative

H.6.Investigation: 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.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 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: 8629713
• MDR Text Key: 146364434
• Report Number: 2243072-2019-00979
• Device Sequence Number: 1
• Product Code: NSC
• 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,foreign
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2019
• 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: 16025002
• Date Manufacturer Received: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other