MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ SYRING ALLERGIST TRAY PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE

Catalog Number	305951
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/20/2018
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 by the (b)(6) department that the bd safetyglide¿ syring allergist tray permanently attached needle are difficult to activate the safety mechanism feature after use.No reports of serious injury or medical intervention noted.
Additional Manufacturer Narrative
Investigation summary: customer returned (3) loose 1ml, 10mm, 26g bd safetyglide allergy syringes with a tray cover from lot # 7026751.No packaging materials from lot # 8053919 were returned with the syringes.Customer states that they are having a bit of a challenge engaging the safety device on the allergy syringe that they are currently using for tb placements one syringe was returned with the safety mechanism fully and properly activated.Both remaining syringes were tested and both were able to activate properly without any observed defects.No defects were observed on any of the returned syringes.A review of the device history record was completed for batch # 8053919.All inspections were performed per the applicable operations qc specifications.There was one (1) notification (b)(4) noted for spinners.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of safety mechanism difficult to activate (safetyglide) with lot #8053919 regarding item #305951.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SAFETYGLIDE¿ SYRING ALLERGIST TRAY PERMANENTLY ATTACHED NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7509338
• Report Number: 1920898-2018-00319
• Device Sequence Number: 11192298
• Product Code: MEG
• UDI-Device Identifier: 00382903059515
• UDI-Public: 00382903059515
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2018

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: 01/31/2023
• Device Catalogue Number: 305951
• Device Lot Number: 8053919
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 04/25/2018
• Initial Report FDA Received Date: 05/11/2018
• Supplement Report FDA Received Date: 05/22/2018
• 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