MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 27G X 5/8IN BD SAFETYGLIDE¿ NEEDLE

Catalog Number	305921
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 by a clinician that the safety sheath on a 27g x 5/8 in bd safetyglide" needle failed to engage bending the needle after use.There was no report of medical intervention.
Additional Manufacturer Narrative
Results: dhr review for batch 6238566 (p/n 305921) was performed.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 6238566 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.One photo was received by bd (b)(4) and evaluated.A single safetyglide needle from a reported batch #6238566 (p/n 305921) was attached to a syringe partially filled with unidentified clear liquid.The safety mechanism was engaged and fully extended.The safety mechanisms tip was not covering the needle tip, leaving it exposed.The needle was observed to be bent in the direction of the safety mechanism approximately half way down the needle length.No visual defects were visible in the safety mechanism in the photo.The safety mechanism is designed for a single-handed activation.When used as intended, the shield will extend and cover the needle tip completely and will not slip off.The defect observed can result from improper operation of the safety mechanism.Conclusion: based on the sample evaluation bd (b)(4) was not able to duplicate or confirm the customer's indicated failure.

• Brand Name: 27G X 5/8IN BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 6980218
• Report Number: 1213809-2017-00218
• Device Sequence Number: 13752192
• Product Code: FMI
• UDI-Device Identifier: 30382903059219
• UDI-Public: 30382903059219
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2018

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: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 305921
• Device Lot Number: 6238566
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2017
• Supplement Date Received by Manufacturer: 10/03/2017
• Initial Report FDA Received Date: 10/26/2017
• Supplement Report FDA Received Date: 01/12/2018
• 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