MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE INTEGRA 22X1-1/2 RB TW; PISTON SYRINGE

Model Number	305313
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: 5 samples were received.They all came in sealed packaging blisters.They all have printed the lot# 9329611.Performed functional test such as retractability and spring presence and they all pass.Root cause could not be determined and failure mode could not be verified.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 # 9329611 for this type of defect or symptom.There was no documentation for this type of defects during the entire production run of this batch.Root cause description: undetermined.
Event or Problem Description
It was reported that needle retraction failure occurred during use with a needle integra 22x1-1/2 rb tw.The following information was provided by the initial reporter, "it was reported that customer heard a popping sound after delivering medication, however the needle was still exposed.Customer called and reported "needle failed to retract , a popping sound was heard after medication delivery but the needle was still exposed" lot 9329611.".

• Brand Name: NEEDLE INTEGRA 22X1-1/2 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9991966
• Report Number: 1911916-2020-00402
• Device Sequence Number: 2967842
• Product Code: MEG
• UDI-Device Identifier: 30382903053132
• UDI-Public: 30382903053132
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/06/2020

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: 01/31/2025
• Device Model Number: 305313
• Device Catalogue Number: 305313
• Device Lot Number: 9329611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2020
• 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