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

Model Number	305918
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/14/2020
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 that safety cap was missing and needle was sticking out of packaging thus affecting sterility with a bd safetyglide¿ needle.The following information was provided by the initial reporter: it was reported that there was no safety cap on needle and needle was poking out of the package.
Additional Manufacturer Narrative
Investigation: two photos displaying the top and bottom view of a fully sealed blister pack from batch 9323614 (p/n 305918) were received and evaluated.It was observed there was a safetyglide needle assembly inside without a shield, which was rejectable per product specification.Potential root cause for the missing shield defect is associated with the defective material from the supplier and insufficient containment.Corrective actions took place to mitigate the occurrence of this defect since the manufacture of this batch.Actions included mechanical modification to the needle line to prevent the unshielded needles from getting to the blisterpack loader by detecting and discarding the defective product.Completed: 16 jan 2020.Since the defects observed are within the acceptable limits, no corrective actions are necessary.Dhr was performed.All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.
Event or Problem Description
It was reported that safety cap was missing and needle was sticking out of packaging thus affecting sterility with a bd safetyglide¿ needle.The following information was provided by the initial reporter: it was reported that there was no safety cap on needle and needle was poking out of the package.

• Brand Name: BD SAFETYGLIDE¿ 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: 10031271
• Report Number: 1213809-2020-00294
• Device Sequence Number: 14199785
• Product Code: FMI
• UDI-Device Identifier: 30382903059189
• UDI-Public: 30382903059189
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 305918
• Device Catalogue Number: 305918
• Device Lot Number: 9323614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/08/2020
• 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