MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305125
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	12/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 25 g bd¿ needle 1 in.Single use, sterile had the needle penetrate through the shield.The following information was provided by the initial reporter:  it was reported by the consumer the needle through the shield resulting in a needle stick.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the 25 g bd¿ needle 1 in.Single use, sterile had the needle penetrate through the shield.The following information was provided by the initial reporter:  it was reported by the consumer the needle through the shield resulting in a needle stick.
Additional Manufacturer Narrative
H6: investigation: it was reported the needle poked through the side of the cap which resulted in a needle stick injury.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly with the needle tip through the plastic shield.Inside of the plastic shield there is a metal rounded mechanism that is thicker than and next to the needle.It goes on one side of the needle hub.It is not clear from the photo which side the needle is coming from.This defect could occur when the needle is recapped though this is off label use.The needle assembly should not be recapped.A device history record review was completed for provided material number 305125, lot number 0274546.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: 25 G BD¿ NEEDLE 1 IN. SINGLE USE, STERILE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13259017
• Report Number: 1911916-2021-01339
• Device Sequence Number: 4761302
• Product Code: FMI
• UDI-Device Identifier: 30382903051251
• UDI-Public: 30382903051251
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 01/31/2026
• Device Model Number: 305125
• Device Catalogue Number: 305125
• Device Lot Number: 0274546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2021
• Supplement Date Received by Manufacturer: 01/19/2022
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown