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

Catalog Number 47264778

Device Problem Mechanical Problem (1384)

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

Event Date 04/30/2019

Event Type  malfunction  

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, a supplemental report will be filed.

Event Description

It was reported that operation difficulty occurred with a pen ii omnitrope pen 5 1.5ml.The following information was provided by the initial reporter, "high resistance: "rapporteur reported that her pen is locking 2 days ago and she can not applying the full dosage, so she needs to pierce 2 times.Not tested with another ampoule.".

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 batches involved in this complaint meet all acceptable quality levels (aql¿s), were 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.Unconfirmed, no issue observed.

Event Description

It was reported that operation difficulty occurred with a pen ii omnitrope pen 5 1.5ml.The following information was provided by the initial reporter, "high resistance: "rapporteur reported that her pen is locking 2 days ago and she can not applying the full dosage, so she needs to pierce 2 times.Not tested with another ampoule.".

• Brand Name: PEN II OMNITROPE PEN 5 1.5ML
• Type of Device: INJECTOR PEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8617575
• MDR Text Key: 145503866
• Report Number: 2243072-2019-00945
• Device Sequence Number: 1
• Product Code: NSC
• UDI-Device Identifier: 00382904726478
• UDI-Public: 382904726478
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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: Lay User/Patient
• Device Expiration Date: 03/22/2021
• Device Catalogue Number: 47264778
• Device Lot Number: 17062002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Initial Date Manufacturer Received: 04/30/2019
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other