MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY

Catalog Number	305536
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the label of a bd allergy tray precisionglide¿ attached needle without safety was incorrect, and stated ¿treatment¿ instead of ¿testing¿ on the label.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned a photo of a tray of 1/2ml, 10mm, 27g allergy syringes from lot # 7072704.Customer states that the label had "treatment" crossed out and "testing" was written.The photo was examined and the tray cover exhibited ¿treatment¿ printed on it.Refer to capa (b)(4) and situation analysis (b)(4).Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.Based on the above, no additional investigation is required at this time.Investigation conclusion: refer to capa (b)(4) and situation analysis (b)(4).

• Brand Name: BD¿ ALLERGY SYRINGE WITH NEEDLE, TRAY
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7180516
• Report Number: 1920898-2017-00430
• Device Sequence Number: 1177068
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• 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): 03/12/2018

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: 02/28/2022
• Device Catalogue Number: 305536
• Device Lot Number: 7072704
• Initial Date Received by Manufacturer: 12/18/2017
• Supplement Date Received by Manufacturer: 12/18/2017
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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