MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 5 ML; PISTON SYRINGE

Model Number	309647
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd¿ luer slip syringe sterile, single use, 5 ml had liquid in the syringe.The following information was provided by the initial reporter: "they found a hand full of the 10 ml syringes that had an oil substance in them and wondered if this was something that came from the manufacture and was still safe to use or if they should remove any that were found to have the oil inside the syringe.".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd¿ luer slip syringe sterile, single use, 5 ml had liquid in the syringe.The following information was provided by the initial reporter: "they found a hand full of the 10 ml syringes that had an oil substance in them and wondered if this was something that came from the manufacture and was still safe to use or if they should remove any that were found to have the oil inside the syringe.".
Additional Manufacturer Narrative
H.6.Investigation: one photo of a 5ml plunger rod and stopper (p/n 309647) was visually evaluated.The photo was of a plunger with a stopper standing on a table.The "oil" substance noted in the verbatim is most likely silicone lubricant used in the assembly process of which the normal expected amount was present.No visual defects were observed in the picture.The condition observed was acceptable per product specification.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.
Event or Problem Description
It was reported that bd¿ luer slip syringe sterile, single use, 5 ml had liquid in the syringe.The following information was provided by the initial reporter: "they found a hand full of the 10 ml syringes that had an oil substance in them and wondered if this was something that came from the manufacture and was still safe to use or if they should remove any that were found to have the oil inside the syringe.".

• Brand Name: BD¿ LUER SLIP SYRINGE STERILE, SINGLE USE, 5 ML
• 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: 13480849
• Report Number: 1213809-2022-00056
• Device Sequence Number: 14793458
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: 30382903096474
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 02/09/2022

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 Expiration Date: 03/31/2026
• Device Model Number: 309647
• Device Catalogue Number: 309647
• Device Lot Number: 1102727
• 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: 01/25/2022
• Supplement Date Received by Manufacturer: 02/09/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 02/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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