MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE; PISTON SYRINGE

Catalog Number	309659
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stopper broke off inside the bd¿ slip-tip disposable tuberculin syringe.This occurred with 5 syringes during use.The following information was provided by the initial reporter: "description: the black tip of the 1ml tuberculin slip type syringe breaks off in the barrel of the syringe.Complaint noticed: during / after use.Patient injury: no".
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 02-may-2023.H6: investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, it was observed that the plunger rod was broken off with the tip inside the stopper.Potential root cause for the plunger rod broken defect is associated with the assembly process.These defects are occurring below an expected rate so no corrective actions will be made at this time.A device history record review showed no rejected inspections or quality issues during the production of the provided batch number that could have contributed to the reported defect.
Event or Problem Description
It was reported that the stopper broke off inside the bd¿ slip-tip disposable tuberculin syringe.This occurred with 5 syringes during use.The following information was provided by the initial reporter: "description: the black tip of the 1ml tuberculin slip type syringe breaks off in the barrel of the syringe.Complaint noticed: during / after use.Patient injury: no.".

• Brand Name: BD¿ SLIP-TIP DISPOSABLE TUBERCULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16729066
• Report Number: 1213809-2023-00357
• Device Sequence Number: 6726801
• Product Code: FMF
• UDI-Device Identifier: 00382903096596
• UDI-Public: 00382903096596
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2023

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: 309659
• Device Lot Number: 2304034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/12/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2022
• 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