MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER-LOK¿ SYRINGE WITH NEEDLE

Catalog Number	309569
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown. device manufacture date: unknown.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 there was a "substance" found inside a 3ml bd¿ luer-lok¿ syringe with needle.In addition, the substance wasn't noticed until drawing up methylpred which is milky white and the substance turned it from white to pink.There was no report of exposure, serious injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: total 11 loose assembled 3ml syringes were received, reported to be from unknown batch # (p/n 309569).The samples were visually evaluated.The samples were found to have pink fluid in a single syringe and loose red/purple residue located at shield, hub and inside the barrel.The residue could be dried medication of customer fluid.The size of pink residue was not greater than level 3.No other defect was observed.Fourier transform infrared spectroscopy (ftir) spectral analysis was conducted on the reddish material, white precipitate material, and pink liquid seen inside the barrel.The ftir analysis shows that the reddish material has components similar to those of ammonium chloride mixed with silicone.The white precipitate material and the pink liquid is likely prednisolone (the medication mentioned in the event description by the customer).No device history record review can be completed as lot number was not provided.Based on the evaluation performed, bd was not able to confirm the customer¿s indicated failure root cause and capa not required as no defects were confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported there was a "substance" found inside a 3ml bd¿ luer-lok¿ syringe with needle.In addition, the substance wasn't noticed until drawing up methylpred which is milky white and the substance turned it from white to pink.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD¿ LUER-LOK¿ SYRINGE WITH NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7535434
• Report Number: 1213809-2018-00293
• Device Sequence Number: 11230580
• Product Code: FMF
• UDI-Device Identifier: 30382903095699
• UDI-Public: 30382903095699
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 309569
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Received by Manufacturer: 04/30/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other