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

Catalog Number	305924
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/12/2019
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 (syringe), pma / 510(k)#: k951254 (needle).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
Material no.305924 batch no.7093907.It was reported that before use of the bd safetyglide¿ shielding hypodermic needle the plunger was not attached to the rubber tip.The following information was provided by the initial reporter: plunger not attached to the rubber tip, no way to draw up vaccine.Slides right to the end if held up.Another package in the box had a defective plunger where the black rubber was "wavy" and fluid leaked past the plunger and out the end of the tube.The nurse was unable to save this product because there was vaccine in it and so it was discarded.
Additional Manufacturer Narrative
No samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.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.
Event or Problem Description
Material no.305924.Batch no.7093907.It was reported that before use of the bd safetyglide¿ shielding hypodermic needle the plunger was not attached to the rubber tip.The following information was provided by the initial reporter: plunger not attached to the rubber tip, no way to draw up vaccine.Slides right to the end if held up.Another package in the box had a defective plunger where the black rubber was "wavy" and fluid leaked past the plunger and out the end of the tube.The nurse was unable to save this product because there was vaccine in it and so it was discarded.

• 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: 9386118
• Report Number: 1213809-2019-01189
• Device Sequence Number: 11443271
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: 30382903059240
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2019

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: 03/31/2022
• Device Catalogue Number: 305924
• Device Lot Number: 7093907
• Initial Date Received by Manufacturer: 11/14/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 12/31/2019
• 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