MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD PRECISIONGLIDE¿ ALLERGY SYRINGE; PISTON SYRINGE

Model Number	305500
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd precisionglide¿ allergy syringe had the needle point penetrate the safety shield.The following information was provided by the initial reporter: " consumer reported needle through shield.".
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd precisionglide¿ allergy syringe had the needle point penetrate the safety shield.The following information was provided by the initial reporter: " consumer reported needle through shield.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-feb-2022.H6: investigation summary: customer returned (1) loose 1ml bd allergy syringe without any packaging.Customer states that the needle was through the shield and there was a needle stick.The returned syringe was examined and exhibited the cannula through the shield, exposing the cannula, which could lead to a needle stick.A review of the device history record was completed for batch #0293194.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to confirm the customer¿s indicated failure.The root cause cannot be determined.

• Brand Name: BD PRECISIONGLIDE¿ ALLERGY SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13459245
• Report Number: 1920898-2022-00073
• Device Sequence Number: 20280098
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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: 10/31/2025
• Device Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: 0293194
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/04/2022
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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