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	07/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7073684 , medical device expiration date: 2022-03-31, device manufacture date: 2017-03-14.Medical device lot #: 6351901, medical device expiration date: 2022-01-31, device manufacture date: 2016-12-16.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 the syringes in the box of bd allergy tray precisionglide¿ attached needle were in question.The label on boxes does not match the product inside the box.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.
Event or Problem Description
It was reported that the syringes in the box of bd allergy tray precisionglide¿ attached needle were in question.The label on boxes does not match the product inside the box.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned (7000) 1/2cc, 27g bd allergy syringes in sealed trays in the shipping carton from lot # 7073684 and (1000) 1/2cc, 27g bd allergy syringes in sealed trays in the shipping carton from lot # 6351901.Customer states that they have the correct syringes, but label on the syringe box was incorrect.All returned trays were examined and all exhibited ¿treatment¿ printed on the tray cover.The shipping cartons were also examined and all exhibited ¿testing¿ printed on the label.Capa (b)(4) and situation analysis mss-17-1005-sa has been opened to address this issue.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.
Event or Problem Description
It was reported that the syringes in the box of bd allergy tray precisionglide¿ attached needle were in question.The label on boxes does not match the product inside the box.There was no report of injury or medical intervention.

• 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: 7781825
• Report Number: 1920898-2018-00608
• Device Sequence Number: 14065180
• Product Code: FMF
• UDI-Device Identifier: 30382903055365
• UDI-Public: 30382903055365
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/25/2018

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 Catalogue Number: 305536
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/24/2018; 07/24/2018
• Initial Report FDA Received Date: 08/14/2018
• Supplement Report FDA Received Date: 08/16/2018; 09/27/2018
• 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