MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that a syringe 0.3ml 30ga 1/2in uf 10bag 500cs separated from the hub during use.The following was reported by the initial reporter: "it was reported that hub separated with needle.Verbatim: consumer reported when removing the orange needle shield the whole needle component comes off with it.Stated this happened with two syringes".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval yes.D10/d11: concomitant medical products: returned to manufacturer on: 2021-03-1 h6: investigation summary: customer returned one syringe with no pouch for identification.This syringe feature 0.3ml graduation markings.The syringe was returned fully intact.Removing the needle shield found that the hub was properly attached to the barrel of the syringe.A needle shield pull force test was performed on this syringe.The needle shield required 5.85 lbs of force to be removed.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.While on the higher end, the pull force required to remove the shield is still within specification.With the needle hub attached and the needle shield being within pull force specification, the report of the hub separating from the barrel could not be confirmed for this sample.A review of the device history record was completed for batch # 0160994 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
Event or Problem Description
It was reported that a syringe 0.3ml 30ga 1/2in uf 10bag 500cs separated from the hub during use.The following was reported by the initial reporter: "it was reported that hub separated with needle.Verbatim: consumer reported when removing the orange needle shield the whole needle component comes off with it.Stated this happened with two syringes.".

• Brand Name: SYRINGE 0.3ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11533113
• Report Number: 1920898-2021-00326
• Device Sequence Number: 3945013
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2021

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: Lay User/Patient
• Device Expiration Date: 06/30/2025
• Device Model Number: 328431
• Device Catalogue Number: 328431
• Device Lot Number: 0160994
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/24/2021
• Supplement Date Received by Manufacturer: 03/26/2021
• Initial Report FDA Received Date: 03/20/2021
• Supplement Report FDA Received Date: 04/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1