MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 1 ML BD LUER SLIP TIP SYRINGE STERILE, SINGLE USE 1 ML TUBERCULIN SLIP TIP SYRIN; SYRINGE, PISTON

Model Number 309659

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  Injury  

Event Description

It was reported that the tuberculin 1ml slip tip syringe would not keep the hub of 30gauge x1/2in bd needle on.It was reported that the upon trying to remove the cap, the whole needle came off the slip tip.It was reported that the friction for the hub of the needle to the syringe was lacking.Fda safety report id# (b)(4).

• Brand Name: 1 ML BD LUER SLIP TIP SYRINGE STERILE, SINGLE USE 1 ML TUBERCULIN SLIP TIP SYRIN
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 12306936
• MDR Text Key: 266202625
• Report Number: MW5103138
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/06/2021

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
• Device Operator: Health Professional
• Device Model Number: 309659
• Device Catalogue Number: 309659
• Device Lot Number: 1090660
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention