MAUDE Adverse Event Report: BECTON DICKINSON PEN II OMNITROPE PEN 10; PEN NEEDLE

Catalog Number 47286578

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

Hold for erika 1.9 it has been reported that the pen ii omnitrope pen 10 has been found experiencing two occurrences of under dosing during use.The following has been provided by the initial reporter: caller described that the normal process of administering the medication to her son would be dialing up the dose on the pen and upon administering if the medication until it stops.If the pen stops before the dial goes to zero, then she would take medicine out of the next cartridge.Recently, she would set the dose and there would not be much in the cartridge.The pen goes all the way down to zero and her son does not appear to get the full dose of medicine.

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 complaint sample revealed a cracked and broken vial retainer.The root cause of the broken vial retainer is most likely material incompatibility.Breaking from material incompatibility is due to the interaction between the polycarbonate of the vial retainer component and dioctyl phthalate found in the pen pouch.Chemical compatibility overview for lexan polycarbonate recommends against the use of diocytl phthalate in conjunction with polycarbonate as it results in failure or severe degradation.Corrective actions have been determined to inform sandoz gmbh of material compatibility with the pen pouch.Preventative action has been established for sandoz to update the pen pouch material.H3 other text : see h.10.

Event Description

It has been reported that the pen ii omnitrope pen 10 has been found experiencing two occurrences of under dosing during use.The following has been provided by the initial reporter: caller described that the normal process of administering the medication to her son would be dialing up the dose on the pen and upon administering if the medication until it stops.If the pen stops before the dial goes to zero, then she would take medicine out of the next cartridge.Recently, she would set the dose and there would not be much in the cartridge.The pen goes all the way down to zero and her son does not appear to get the full dose of medicine.

• Brand Name: PEN II OMNITROPE PEN 10
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9162211
• MDR Text Key: 176105510
• Report Number: 2243072-2019-02217
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/02/2021
• Device Catalogue Number: 47286578
• Device Lot Number: 18258002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Manufacturer Received: 09/20/2019
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: 09/20/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other