MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿; ANTISTICK SYRINGE

Model Number	305945
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); Foreign Body In Patient (2687)
Date of Event	04/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 tuberculin syringe with needle safetyglide¿ broke off in the patient and the health care provider was stuck with the dirty needle.It was reported needle broke off.Event date: (b)(6) 2022.Awareness date: 7-apr-2022.Complaint: the syringe broke off in the patient, the needle stuck the rn.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a photo of a 1ml safetyglide syringe.Customer states that the needle broke off.The photo was examined and exhibited a broken plunger rod.A review of the device history record was completed for batch #1257281.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Embecta was able to duplicate or confirm the customer¿s indicated failure.Dhr and l2l dispatches were reviewed, nothing pertaining to this defect was found.No root cause can be found.
Event or Problem Description
It was reported that bd tuberculin syringe with needle safetyglide¿ broke off in the patient and the health care provider was stuck with the dirty needle." it was reported needle broke off." verbatim: event date: 6-apr-2022.Awareness date: 7-apr-2022.Complaint: the syringe broke off in the patient, the needle stuck the rn.

• Brand Name: BD TUBERCULIN SYRINGE WITH NEEDLE SAFETYGLIDE¿
• Common Device Name: ANTISTICK 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: 14274927
• Report Number: 1920898-2022-00307
• Device Sequence Number: 14913648
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• 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): 05/26/2022

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: Other
• Device Model Number: 305945
• Device Catalogue Number: 305945
• Device Lot Number: 1257281
• 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: 04/07/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 06/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown