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

Catalog Number	320122
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	10/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event is unknown.The date received by the manufacturer is used.(b)(4).Device evaluation: results- a sample is not available for investigation.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion- without a sample, an absolute root cause for this incident cannot be determined.
Event or Problem Description
It was reported that the customer was recapping the needle after her injection and received a needle stick injury to her finger.

• Brand Name: 32 G X 4 MM BD ULTRA FINE¿ INSULIN PEN NEEDLE
• Common Device Name: HYPODERMIC PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 6017378
• Report Number: 9616656-2016-00064
• Device Sequence Number: 13629391
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K131358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 10/10/2016

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 320122
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2016
• Initial Report FDA Received Date: 10/11/2016
• 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