MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ TUBERCULIN SYRINGE; PISTON SYRINGE

Catalog Number 305945

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/02/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.A dhr check was not performed as the lot number is ¿unknown¿ for this complaint.As no samples and/or photo(s) were received the investigation concluded: unconfirmed: embecta was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the above, no additional investigation and no capa/sa is required at this time.

Event Description

It was reported that the bd safetyglide¿ tuberculin syringe needle was blocked during the vaccine injection.The following information was provided by the initial reporter: caller states they are looking for syringe needle combination (27g needle) to accommodate the fda guidelines for the monkeypox vaccine.They are currently using product code: 305945 and 305946 and are unable to get the full 0.1ml (5th dose) from the vial.

• Brand Name: BD SAFETYGLIDE¿ TUBERCULIN SYRINGE
• Type of Device: 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: 15489474
• MDR Text Key: 306265711
• Report Number: 1920898-2022-00649
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: (01)00382903059454
• 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
• Report Date: 09/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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