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

Catalog Number	309659
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 500 bd¿ slip-tip disposable tuberculin syringes were found with foreign matter inside them.The following information was provided by the initial reporter: "as per complaint, pharmacy found black dot/powder like material on the plunger of the multiple 1ml bd syringe from the lot 2355450.Can you please confirm these syringes did not come in contact with any patients and there was no harm? ans: yes, i confirm that these syringes did not come in contact with any patient and there was no harm.".
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.
Event or Problem Description
It was reported that 500 bd¿ slip-tip disposable tuberculin syringes were found with foreign matter inside them.The following information was provided by the initial reporter: "as per complaint, pharmacy found black dot/powder like material on the plunger of the multiple 1ml bd syringe from the lot 2355450.Can you please confirm these syringes did not come in contact with any patients and there was no harm? ans: yes, i confirm that these syringes did not come in contact with any patient and there was no harm".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 23-may-2023 h6: investigation summary five samples were provided to our quality team for investigation.Through visual inspection, it was observed that one syringe has a 1/4" scrape on the flange and four syringes have a grease-like foreign matter present on the side of the flange.Potential root cause for the damaged barrel defect and foreign matter non-fluid path is associated with the assembly process.Production database and technical logs for lot 2355450 were reviewed.An issue pertaining to the damaged barrel defect was documented in the production database and technical log.

• 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: 16920262
• Report Number: 1213809-2023-00501
• Device Sequence Number: 15186124
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2023

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: 2355450
• 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: 04/20/2023
• Supplement Date Received by Manufacturer: 06/19/2023
• Initial Report FDA Received Date: 05/12/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2022
• 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