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

Catalog Number 47286578

Device Problem Misconnection (1399)

Patient Problem Pain (1994)

Event Date 05/22/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that pen ii omnitrope pen 10 leaked.The following information was provided by the initial reporter: high resistance, because the pen is hard the application hurts the patient.

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 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.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.

Event Description

It was reported that pen ii omnitrope pen 10 leaked.The following information was provided by the initial reporter: high resistance, because the pen is hard the application hurts the patient.

• 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: 8675130
• MDR Text Key: 147342038
• Report Number: 2243072-2019-01120
• Device Sequence Number: 1
• Product Code: FMF
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/02/2019

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: 03/06/2020
• Device Catalogue Number: 47286578
• Device Lot Number: 17045001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/06/2019
• Supplement Dates Manufacturer Received: 05/22/2019
• Supplement Dates FDA Received: 07/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other