MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ SHIELDING HYPODERMIC NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305924
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of a bd safetyglide¿ shielding hypodermic needle leaked around the plunger.
Event or Problem Description
It was reported that during use of a bd safetyglide¿ shielding hypodermic needle leaked around the plunger.
Additional Manufacturer Narrative
H.6.Investigation: one 3ml syringe with safetyglide needle in an open blister pack from batch #6090858 (p/n 305924) was received and visually evaluated.The syringe contained clear residue droplets and the safety shield was deployed.Initially, it was observed the stopper appeared to not be seated properly on the end of the plunger rod.After the plunger rod was removed from the syringe and the stopper was taken off the plunger rod, it was observed the end of the plunger rod was bent.Potential root cause for the leakage past stopper defect is associated with the damaged plunger rod.The end of the plunger rod was bent which prevented the stopper from being seated properly.The damage to the plunger rod occurred during the assembly or material handling process.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.

• Brand Name: BD SAFETYGLIDE¿ SHIELDING HYPODERMIC 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: 8287379
• Report Number: 1213809-2019-00129
• Device Sequence Number: 1911605
• Product Code: MEG
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 03/31/2021
• Device Catalogue Number: 305924
• Device Lot Number: 6090858
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/29/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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