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	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple pma / 510(k)#s reported to be involved.The information for each 510(k) number is as follows: pma / 510(k)#: k980987; pma / 510(k)#: k951254.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 vaccine leaked from the back of the bd luer-lok¿ syringe with bd safetyglide¿ safety needle around the plunger during use, resulting in an incomplete dosage for the client.The following information was provided by the initial reporter: "upon administration of vaccine, vaccine came out the back of syringe around the plunger instead of going forward through syringe.Client did not get full dose of vaccine as a result.".
Event or Problem Description
It was reported that the vaccine leaked from the back of the bd luer-lok¿ syringe with bd safetyglide¿ safety needle around the plunger during use, resulting in an incomplete dosage for the client.The following information was provided by the initial reporter: "upon administration of vaccine, vaccine came out the back of syringe around the plunger instead of going forward through syringe.Client did not get full dose of vaccine as a result.".
Additional Manufacturer Narrative
Investigation: four sealed packaged 3ml safetyglide combo syringes with needles were received, confirmed to be from batch #6062973 (b)(4).The samples arrived in an unprotected envelope, which appears to have been stepped on during transport.The samples were visually evaluated.No visual defects observed.The samples were tested for leakage past stopper per procedure.All samples passed with no leakage observed.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.The reported defect was not identified in the samples received.

• 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: 8515296
• Report Number: 1213809-2019-00443
• Device Sequence Number: 2869223
• Product Code: FMI
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.10.
• 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): 05/23/2019

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: 02/28/2021
• Device Catalogue Number: 305904
• Device Lot Number: 6062973
• Initial Date Received by Manufacturer: 03/29/2019
• Supplement Date Received by Manufacturer: 03/29/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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