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

Model 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	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.(b)(6) usa has been used as a default.Investigation summary: one photo was provided.It shows a packaging blister with the lot# and the expiration date as of 2024-06-29; the coc the customer got from the system has expiration date of 2024-02-29.The production orders are created the previous month than the month planned to be produced; sometimes the production order is delayed and produced at later month(s) than originally planned.When the production order is produced the expiration date is created/ printed on the labeling is based on the actual manufacturing month.In this case the production planning didn¿t update the system with the expiration date based on the actual manufacturing date.A revised coc will be issued to the customer and production planning is not anymore carrying over for month open production orders.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: 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.Root cause description: production planning- in this case the production planning didn¿t update the system with the expiration date based on the actual manufacturing date.Rationale: capa not required at this time.
Event or Problem Description
It was reported that needle 27ga 1-1/2in had incorrect label information.This was discovered before use.The following information was provided by the initial reporter: material no: 301629 batch no: 9030562.It was reported that expiration date on the package of the needle is different from the expiration date on the coc.

• 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: 9993355
• Report Number: 1911916-2020-00406
• Device Sequence Number: 2967845
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: 30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/16/2020

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 Model Number: 301629
• Device Catalogue Number: 301629
• Device Lot Number: 9030562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2020
• Initial Report FDA Received Date: 04/23/2020
• 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