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

Catalog Number	47286578
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the pen ii omnitrope pen 10 started to malfunction spring was jammed and could not push down.When administering omnitrope pen jammed halfway through injection and maybe half of the dose was administered.The following information was provided by the initial reporter: plunger stuck: ¿started malfunctioning 4 days ago".He added that he "cannot push it down" and that the "spring got jammed".Due to the issue, he was not able to give his daughter her omnitrope "yesterday".He reported that the pen "jammed halfway through" when trying to administer a dose.He added that "half" of the dosage may have been administered, but could not be certain.He tried the pen again and stated it "jammed".He did not try to give omnitrope yesterday as he did not want to "prick" his daughter with the needle if it is malfunctioned as it "hurts her".
Additional Manufacturer Narrative
Investigation summary: 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 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.
Event or Problem Description
It was reported that during use of the pen ii omnitrope pen 10 started to malfunction spring was jammed and could not push down.When administering omnitrope pen jammed halfway through injection and maybe half of the dose was administered.The following information was provided by the initial reporter: plunger stuck: ¿started malfunctioning 4 days ago".He added that he "cannot push it down" and that the "spring got jammed".Due to the issue, he was not able to give his daughter her omnitrope "yesterday".He reported that the pen "jammed halfway through" when trying to administer a dose.He added that "half" of the dosage may have been administered, but could not be certain.He tried the pen again and stated it "jammed".He did not try to give omnitrope yesterday as he did not want to "prick" his daughter with the needle if it is malfunctioned as it "hurts her".

• Brand Name: PEN II OMNITROPE PEN 10
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8647290
• Report Number: 2243072-2019-01026
• Device Sequence Number: 11334187
• Product Code: FMI
• UDI-Device Identifier: 00382904728656
• UDI-Public: 382904728656
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/04/2019
• Device Catalogue Number: 47286578
• Device Lot Number: 15338004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 05/28/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other