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	05/15/2018
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 a bd safetyglide¿ shielding hypodermic the needle was found leaking as "during injection of vaccine, the majority of the vaccine passed the seal of the plunger and backed to the barrel of the syringe.The client did not receive a full dose and they were required to inject the child a second time to administer a complete full dose.Upon closer inspection of the syringe, it was noted that the plunger was misshaped on one side." there was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
H.6.Investigation summary: two photos were received showing 3ml syringes reported to be from batch # 7093907 (p/n # 305924).The photos were evaluated.The photos show one loose syringe with an insecure stopper ¿ the stopper was not fully attached to the plunger rod tip.The insecure stopper observed is rejectable per product specification.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.In addition, the potential root cause for the insecure stopper defect is associated with the assembly process.No corrective actions are necessary based on the defective rate identified.Investigation conclusion: potential root cause for the insecure stopper defect is associated with the assembly process.
Event or Problem Description
It was reported with the use of a bd safetyglide¿ shielding hypodermic the needle was found leaking as "during injection of vaccine, the majority of the vaccine passed the seal of the plunger and backed to the barrel of the syringe.The client did not receive a full dose and they were required to inject the child a second time to administer a complete full dose.Upon closer inspection of the syringe, it was noted that the plunger was misshaped on one side." there was no report of exposure, injury, or medical intervention.

• 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: 7648761
• Report Number: 1213809-2018-00382
• Device Sequence Number: 168962
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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: 03/31/2022
• Device Catalogue Number: 305924
• Device Lot Number: 7093907
• Initial Date Received by Manufacturer: 06/07/2018
• Supplement Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/19/2018
• 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