MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 1323475; medical device expiration date: 31-oct-2026; device manufacture date: 19-nov-2021.Medical device lot #: 2091531; medical device expiration date: 31-mar-2027; device manufacture date: 01-apr-2022.
Event or Problem Description
It was reported that 3 of the bd¿ slip-tip syringe with attached needle had no markings.The following information was provided by the initial reporter: no markings on syringe.
Additional Manufacturer Narrative
Investigation summary: two photos were provided to our quality team for investigation.Through visual inspection, it was observed that the barrel is damaged and missing all its scale markings.Potential root cause for the missing print and barrel damaged defects is associated with the marking process.A device history record review was completed for provided lot numbers 1323475 and 2091531.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defects.
Event or Problem Description
It was reported that 3 of the bd¿ slip-tip syringe with attached needle had no markings.The following information was provided by the initial reporter: no markings on syringe.

• Brand Name: BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE
• 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 ; 8015296192
• MDR Report Key: 16383632
• Report Number: 1213809-2023-00090
• Device Sequence Number: 14724316
• Product Code: FMF
• UDI-Device Identifier: 00382903095971
• UDI-Public: 00382903095971
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2023

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: 309597
• Device Lot Number: SEE H.10
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 03/04/2023
• Initial Report FDA Received Date: 02/15/2023
• Supplement Report FDA Received Date: 03/19/2023
• 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