MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML LL W/NDL SFTYGLD 23X1 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305905
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: it was reported by the distributor that the needle did not retract after usage.To aid in the investigation, one photo was received for evaluation by our quality team.The photo shows the packaging blister top web.As a sample was unavailable for return, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 305905, lot number 1021251.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Investigation conclusion: based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.With no sample analysis a probable root cause could not be offered.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl sftygld 23x1 rb experienced needle retraction failure.The following information was provided by the initial reporter: material no.: 305905 batch no.: 1021251.It was reported that the needle did not retract after usage.The defective syringe was discarded because of safety concerns and below is the packaging and the lot#1021251.The current inventory i have in stock has a different lot number of this product, there was a previous occurrence of similar issue with this product on the same unit some time ago, but this is first reporting to my attention.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 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: 12007716
• Report Number: 1911916-2021-00560
• Device Sequence Number: 19935681
• Product Code: FMI
• UDI-Device Identifier: 30382903059059
• UDI-Public: 30382903059059
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2025
• Device Model Number: 305905
• Device Catalogue Number: 305905
• Device Lot Number: 1021251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1