MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 27GA 1-1/2IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	301629
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one (1) photo was provided by the customer for investigation.The photo shows a picture of a box label along with a copy of the packing slip.The box label gives an expiration date of 2024-06-29 and the packing slip shows a expiration date of 2/29/2024.Based on the photo provided by the customer and the production date in the batch record bd acknowledges that the packing slip has the wrong expiration date on it.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.Investigation conclusion: a complaint history check was performed and this is the 2nd related complaint reported with the defect/condition of label content incorrect for lot #9030562 item #301629.A device history record (dhr) review was performed on the batches associated with this investigation.The dhr review did not reveal any defects or issues reported and no quality notifications were issued.The dhr review revealed that the batch was packaged on 10-06-2019.Root cause description: based on the photo provided by the customer and the production date in the batch record bd acknowledges that the packing slip has the wrong expiration date on it.Rationale: bd acknowledges that based on the photo provided by the customer and the production date in the batch record bd acknowledges that the packing slip has the wrong expiration date on it.As the expiration date is correct on the box no corrective or preventative action is proposed in the scope of this complaint.
Event or Problem Description
It was reported that the needle 27ga 1-1/2in experienced an incorrect expiration date noted prior to use.The following information was provided by the initial reporter: material no.301629, batch no.9030562.Complaint 2 of 2.The packing slip for item 301629 lot# 9030562 has an expiration of 02/29/2024 but the box is printed with 6/29/2024.Email 7/10/2019: the case was found on (b)(6) 2019.

• Brand Name: NEEDLE 27GA 1-1/2IN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8833662
• Report Number: 1911916-2019-00739
• Device Sequence Number: 2534586
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: 30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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: 02/29/2024
• Device Catalogue Number: 301629
• Device Lot Number: 9030562
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/26/2019
• 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