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

Catalog Number	309644
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 a bd luer-lok¿ syringe with bd precisionglide¿ needle had white residue on it.There was no report of exposure, serious injury, or medical intervention.
Event or Problem Description
It was reported that a bd luer-lok¿ syringe with bd precisionglide¿ needle had white residue on it.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: three photos and one loose 10ml assembled syringe with needle was received and reported to be from batch #8131751 (p/n 309644).The sample was visually evaluated.The needle cannula was found to have a piece of white foreign matter on exterior.The foreign matter appears to be the same epoxy used in the needle assembly process.The foreign matter is level three in size, which is rejectable 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.Potential root cause for the foreign matter defect is associated with the needle assembly process.No corrective actions are necessary based on the defective rate identified.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.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ 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: 7894456
• Report Number: 1213809-2018-00618
• Device Sequence Number: 11121221
• Product Code: FMF
• UDI-Device Identifier: 30382903096443
• UDI-Public: 30382903096443
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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 Expiration Date: 04/30/2023
• Device Catalogue Number: 309644
• Device Lot Number: 8131751
• Initial Date Received by Manufacturer: 08/31/2018
• Supplement Date Received by Manufacturer: 08/31/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/15/2018
• 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