MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 brown foreign matter was found inside the bd syringe luer-lok¿ tip with bd precisionglide¿ needle before use during a visual inspection.The following information was provided by the initial reporter: "during component check-in, the site noticed one of the syringes had a brown foreign substance present inside the syringe.The other syringes passed the visual inspection test.".
Event or Problem Description
It was reported that brown foreign matter was found inside the bd syringe luer-lok¿ tip with bd precisionglide¿ needle before use during a visual inspection.The following information was provided by the initial reporter: "during component check-in, the site noticed one of the syringes had a brown foreign substance present inside the syringe.The other syringes passed the visual inspection test.".
Additional Manufacturer Narrative
H.6.Investigation: two photos and two 3ml syringes with needles in fully sealed blister packs confirmed to be from batch 9098784 (p/n 309572) were received and evaluated.It was observed the packages were not properly perforated and were rejectable per product specification.It was also observed one of the plunger rods of one of the syringes contained a brown foreign matter substance.It appeared to be oil mixed with silicone and was larger than level 3 in size and was rejectable per product specification.Furthermore, 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.Potential root cause for the improper perforation defect is associated with the packaging process.Potential root cause for the foreign matter defect is associated with the molding process.Most likely the observed foreign matter is oil used to lubricate the molding machines.

• Brand Name: BD SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8842356
• Report Number: 1213809-2019-00783
• Device Sequence Number: 1561553
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: 30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2019

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 Expiration Date: 03/31/2024
• Device Catalogue Number: 309572
• Device Lot Number: 9098784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/16/2019
• 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