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	10/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd precisionglide¿ allergy syringe had a needle that had penetrated the shield.Staff member obtained clean needle stick injury.The following information was provided by the initial reporter: it was reported that it was reported that "the needle was sticking through the cap and stuck a staff member.".
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation: the photos was received by bd for evaluation.A quality engineer was able to review the photos of a 1ml syringe from lot # 1102219 regarding item # 305500 with the reported issue of ¿needle was sticking through the cap and stuck a staff member¿.The photos were examined and exhibited the cannula bent through the shield, exposing the cannula, which could lead to a needle stick.A review of the device history record was completed for batch #1102219.All inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the samples and/or photo(s) received the investigation concluded that bd was able to duplicate or confirm the indicated failure.Probable root cause is a misalignment at the shielder dial that caused the cannula to be bent before the shield was attached.H3 other text: see h10.
Event or Problem Description
It was reported that the bd precisionglide¿ allergy syringe had a needle that had penetrated the shield.Staff member obtained clean needle stick injury.The following information was provided by the initial reporter: it was reported that it was reported that "the needle was sticking through the cap and stuck a staff member.".

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12823487
• Report Number: 1920898-2021-01196
• Device Sequence Number: 5697007
• Product Code: FMF
• UDI-Device Identifier: 30382903055006
• UDI-Public: 30382903055006
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 12/01/2021

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: 04/30/2026
• Device Model Number: 305500
• Device Catalogue Number: 305500
• Device Lot Number: 1102219
• 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: 10/19/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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