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

Catalog Number	309643
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 the bd luer-lok¿ syringe with bd precisionglide¿ needle was "broken longitudinally" during use and "made a blood splatter where the whole room was splashed with blood and the doctor's eyes were also exposed".However, there was no medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: three photos and one 10ml syringe with needle in a fully sealed blister pack confirmed to be from batch #8010905 (p/n 309643) were received and visually evaluated.The photos showed significant blood splatter in a lab room and on a doctor.There were no cracks or any other defects observed in the physical sample.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 root cause not defined since defects were not confirmed in photos/samples received.No corrective actions recommended since product defect was not confirmed.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe with bd precisionglide¿ needle was "broken longitudinally" during use and "made a blood splatter where the whole room was splashed with blood and the doctor's eyes were also exposed".However, there was no medical intervention reported.

• Brand Name: BD LUER-LOK¿ SYRINGE 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: 8210295
• Report Number: 1213809-2018-01019
• Device Sequence Number: 16689115
• Product Code: FMF
• UDI-Device Identifier: 30382903096436
• UDI-Public: 30382903096436
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: Health Professional
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 309643
• Device Lot Number: 8010905
• Initial Date Received by Manufacturer: 12/13/2018
• Supplement Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/15/2019
• 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