MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD AUTOSHIELD DUO SAFETY PEN NEEDLE 30GX 5MM

Catalog Number	329705
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/28/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter phone #: (b)(6).Device evaluation: the used sample was discarded in the safety container.The device was retrieved, along with 6 additional devices.It is uncertain which of these 7 devices is the suspect device.The samples have been returned to the manufacture site.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
It was reported that a nurse received a needle stick injury to her left hand and finger when the bd autoshield duo safety pen needle was removed from the pen.The nurse confirmed that the safety mechanism was activated during the injection.There was no notice of insulin leakage or other abnormal concerns during the injection.The patient does not have an infectious disease and no additional medical intervention was provided to either the patient or nurse as a result of this incident.
Additional Manufacturer Narrative
Device evaluation: result - bd received 7 samples from the reported catalog number 329705, lot number 5006558.Photos were also received for evaluation.A visual inspection of 6 samples found the safety mechanism to be activated correctly.The remaining sample was found to have a bend on the patient end needle.The sample was inspected and found that the safety mechanism was not activated.An activation test was carried out and the safety mechanism activated correctly.Quality engineering performed a bench test with normal production samples.Device activation testing was conducted.It was found that by applying minimal force during device activation, it was possible to recreate the observed defect.A review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5006558.Conclusion - upon inspection of the returned devices, it was noted that 6 of the devices had the safety mechanism activated correctly.There is evidence that the devices had been used.On the 7th sample, the patient end of the needle appeared to be bent.It was not activated but the device functioned correctly once the safety mechanism was activated.No defects in the device were observed.It was noted by the engineer that when the autoshield duo pen needle is injected into the skin and the skin is loose around the injection site, the safety mechanism may not activate.This may also have a bent appearance.The bench test determined it was possible to recreated the observed defect when minimal force is applied.The device was found to activate correctly when the applied force was increased.

• Brand Name: BD AUTOSHIELD DUO SAFETY PEN NEEDLE 30GX 5MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 5374761
• Report Number: 9610847-2016-00002
• Device Sequence Number: 16203583
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110703
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Report Date (Section B): 01/28/2016

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: Nurse
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 329705
• Device Lot Number: 5006558
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/18/2016
• 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