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

Model Number 305945

Device Problem Break (1069)

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 04/06/2022

Event Type  Injury  

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 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.

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 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¿
• Type of Device: 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
• MDR Text Key: 293100018
• Report Number: 1920898-2022-00307
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903059455
• UDI-Public: 30382903059455
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention