MAUDE Adverse Event Report: BECTON DICKINSON BD PEN II OMNITROPE PEN 5 1.5ML; PEN NEEDLE

Catalog Number 47264778

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 08/22/2019

Event Type  malfunction  

Manufacturer Narrative

In this mdr, bd corporate headquarters in (b)(4) has been listed as (b)(4) is an oem manufacturing site.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd pen ii omnitrope pen 5 1.5ml is leaking medication.Patient stated that he has lost quite a bit of medication the following information was provided by the initial reporter: the pt states his pen is leaking medicine and he has lost quite a bit of medication.

Event Description

It was reported that the bd pen ii omnitrope pen 5 1.5ml is leaking medication.Patient stated that he has lost quite a bit of medication the following information was provided by the initial reporter: the pt states his pen is leaking medicine and he has lost quite a bit of medication.

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 of the returned complaint samples revealed no visible damage to the pen.An injection sequence was executed using a 29g x 12.7mm 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) 4 3 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.H3 other text : see h.10.

• Brand Name: BD PEN II OMNITROPE PEN 5 1.5ML
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9145891
• MDR Text Key: 176106965
• Report Number: 2243072-2019-02181
• 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,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/03/2022
• Device Catalogue Number: 47264778
• Device Lot Number: 18109003
• Date Manufacturer Received: 09/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other