MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE 3ML

Catalog Number	309588
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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-lok¿ syringe 3ml contained foreign matter.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd luer-lok¿ syringe 3ml contained foreign matter.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation summary: one 3ml syringe with a detached shielded needle and an opened blisterpack from batch #8092913 (p/n 309588) were received and evaluated.The sample had signs of use and manipulation as evidenced by unidentified clear liquid droplets inside the syringe and wet blisterpack.The needle shield appeared to have a dark foreign matter material in form of a droplet near its tip, larger than level 3 in size.The foreign matter could not be further evaluated nor identified due to the contaminated nature of the sample and the location of foreign matter.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.Since the sample was received used and manipulated, it is not possible to determine the nature and origin of the foreign matter, nor is it possible to confirm that the foreign matter originated at the manufacturing facility.The reported defect could not be confirmed to originate at the manufacturing facility.Fourier transform infrared spectroscopy(ftir) spectral analysis was completed on the dark material observed in the shield.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood.

• Brand Name: BD LUER-LOK¿ SYRINGE 3ML
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8019829
• Report Number: 1213809-2018-00722
• Device Sequence Number: 13798122
• Product Code: FMF
• UDI-Device Identifier: 00382903095889
• UDI-Public: 00382903095889
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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,health profession
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2019

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: 03/31/2023
• Device Catalogue Number: 309588
• Device Lot Number: 8092913
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 10/30/2018
• Supplement Report FDA Received Date: 01/22/2019
• 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