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

Catalog Number	305945
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/28/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17924960
• Report Number: 1920898-2023-00695
• Device Sequence Number: 12430146
• Product Code: MEG
• UDI-Device Identifier: 00382903059454
• UDI-Public: 00382903059454
• 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
• Report Date (Section B): 10/04/2023

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 Catalogue Number: 305945
• Device Lot Number: UNKNOWN
• 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: 09/28/2023
• Initial Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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