MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305145
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo was provided.It shows packaging blisters from the top and bottom.The lot# was printed.The expiration date is missing.This would have happened during the multivac packaging process.The bottom web is formed to create a kind of nest and the part is placed in the "nest".Then the top web is placed, and the blister is sealed, then the variable data is printed.In this case the missing variable data was not printed and was not detected in the next processes.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.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: this is the 1st complaint for lot # 9057712 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: this would have happened during the multivac packaging process.Rationale: capa not required at this time.
Event or Problem Description
It was reported that 8 needles 23x1 rb experienced no label or missing label information.Product defect was noted prior to use.The following information was provided by the initial reporter: material no.: 305145 batch no.: 9057712.Syringes missing expiration date and lot numbers missing numbers/hard to read.

• Brand Name: NEEDLE 23X1 RB
• 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: 9868320
• Report Number: 1911916-2020-00285
• Device Sequence Number: 16307163
• Product Code: FMI
• UDI-Device Identifier: 30382903051459
• UDI-Public: 30382903051459
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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 Model Number: 305145
• Device Catalogue Number: 305145
• Device Lot Number: 9057712
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/23/2020
• 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