MAUDE Adverse Event Report: BECTON DICKINSON AND CO. 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE

Catalog Number 320122

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 09/19/2016

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.Medical device expiration date: this device does not have an expiration date.Udi #: (b)(4).

Event Description

It was reported that the customer's pen needles are not working during delivery.There are no problems during prime but "no medicine flows when pen dialed to 0.8".The customer reported getting sick and was sleeping a lot but was unsure of the reason.She went to her endocrinologist "a few weeks ago" and had labs drawn.Her humatrope levels were down and it was determined that she wasn't getting enough medicine.No additional treatment was provided by her doctor and the customer reports being okay at the time of notification to bd.The customer states she rotates injection sites and did not note any bent needles.She has been using pen needles for 20 years.

Manufacturer Narrative

Device evaluation: result - a sample was not returned for evaluation.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Conclusions - as there was no actual returned sample for evaluation, an absolute root cause for this incident cannot be determined.

• Brand Name: 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE
• Type of Device: INSULIN PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6017116
• MDR Text Key: 57053201
• Report Number: 9616656-2016-00059
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131358
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 10/21/2016

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 Catalogue Number: 320122
• Device Lot Number: 5265117
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention