MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305904
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/25/2018
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 with the use of the bd luer-lok¿ syringe with bd safetyglide¿ safety needle there was an issue with the needle separated from the hub and remained in the patient.It was reported that ¿the needle was removed with the use of a cotton ball¿.
Additional Manufacturer Narrative
Investigation summary: 3 sealed packaged safetyglide combo syringes with needles were received, confirmed to be from batch #7302906 (p/n 305904).They were visually evaluated.No visual defects were observed.Since the reported defect is associated with the needle component, the samples were forwarded to the needle manufacturing plant for testing and evaluation.Samples were forwarded to the needle manufacturing plant for testing and evaluation.No defects confirmed to be associated with the syringe manufacturing and packaging plant.Three representative samples were received.They are in sealed packaging blisters.They were visually inspected finding no defects or issues.They were tested for cannula pull force, the values were within product specification.A device history record review for the finished product and cannula batches showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported with the use of the bd luer-lok¿ syringe with bd safetyglide¿ safety needle there was an issue with the needle separated from the hub and remained in the patient.It was reported that ¿the needle was removed with the use of a cotton ball¿.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD SAFETYGLIDE¿ SAFETY NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8134305
• Report Number: 1213809-2018-00850
• Device Sequence Number: 13869280
• Product Code: FMI
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• 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: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2019

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: 10/31/2022
• Device Catalogue Number: 305904
• Device Lot Number: 7302906
• Initial Date Received by Manufacturer: 11/14/2018
• Supplement Date Received by Manufacturer: 11/14/2018
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 03/16/2019
• 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