MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NEEDLE AUTOSHIELD DUO 30GX5MM

Catalog Number	329705
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the pen needle autoshield duo 30gx5mm experienced safety shield failure.The following information was provided by the initial reporter: after injection, the safety mechanism was not activated.
Additional Manufacturer Narrative
H.6.Investigation: one open 30g x 5mm safety pen needle sample was returned from lot.No.0020463, cat.No.329705.Visual examination was carried out on the returned sample and it was observed that the patient end of the cannula was bent and caught on the outer shield causing non activation of the non patient end shield.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 as per the applicable operations and met qc specifications.As the sample returned was open it is not possible to confirm this defect to be manufacturing related.H3 other text : see h.10.
Event or Problem Description
It was reported that the pen needle autoshield duo 30gx5mm experienced safety shield failure.The following information was provided by the initial reporter: after injection, the safety mechanism was not activated.

• Brand Name: PEN NEEDLE AUTOSHIELD DUO 30GX5MM
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 11102153
• Report Number: 9616656-2020-01311
• Device Sequence Number: 3773611
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 329705
• Device Lot Number: 0020463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Received by Manufacturer: 12/03/2020
• Supplement Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 12/31/2020
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1