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

Catalog Number	309626
Medical Device Problem Code	Fungus in Device Environment (2316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that the bd¿ luer slip-tip syringe with attached needle experienced mold on packaging.The following information was provided by the initial reporter: customer advised 1 out of 8 cs was molded.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Examination of the product involved may provide clarification as to the cause for the reported failure.

• Brand Name: BD¿ LUER 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: 15794679
• Report Number: 1213809-2022-00974
• Device Sequence Number: 17332068
• Product Code: FMF
• UDI-Device Identifier: 00382903096268
• UDI-Public: 00382903096268
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 11/04/2022

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: 309626
• Device Lot Number: 2215902
• 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: 10/18/2022
• Initial Report FDA Received Date: 11/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• 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