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

Catalog Number 305945

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 09/28/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.4.The initial reporter also notified the fda on 28-sep-2023.Medwatch report # mw5145668.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd safetyglide¿ tuberculin syringe separates causing leakage.The following information was provided by the initial reporter: syringe/needle that was not connected correctly.Upon injecting into the vial, the medication leaked from the syringe and rendered the product unusable.Our psr for xiaflex on the call initially was handling the replacement procedure.Counseled her to let the staff know to initially tighten the syringe after opening just in case they come slightly loose from the manufacturer as that can happen but it could have been a defective device as well.Unknown if patient missed a dose or experienced an adverse event as a result of defective syringe.Unknown if defective syringe is available for return.No further information.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17924960
• MDR Text Key: 325948496
• Report Number: 1920898-2023-00695
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: 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: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• 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: 09/28/2023
• 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