MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928857
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).
Event or Problem Description
It was reported that an unspecified number of syringes 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no: 928857 batch no: 9301568.Consumer reported: shields are hard to remove and when he eventually gets them off, the needle hub separates.Stated, on some syringes, when shield is removed, the needle is bent at a 40 degree angle, (not able to use).No injury to report.Date of event: unknown.
Event or Problem Description
It was reported that an unspecified number of syringes 0.5ml 31ga 8mm 10bag 500 pl/wg experienced hub separation from the device during use.The following information was provided by the initial reporter: material no: 928857 batch no: 9301568.Consumer reported: shields are hard to remove and when he eventually gets them off, the needle hub separates.Stated, on some syringes, when shield is removed, the needle is bent at a 40 degee angle, (not able to use).No injury to report.Date of event: unknown.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/29/2020.H.6.Investigation: customer returned (4) 1/2cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 9301568.Customer states that the shields are hard to remove and when he eventually gets them off, the needle hub separates and on some syringes, when shield is removed, the needle is bent at a 40 degree angle.All returned syringes were examined and one sample exhibited the hub-needle/shield assembly separated from the barrel and one sample exhibited a bent cannula.The remaining syringes were tested to determine the shield removal forces (specs: shield removal force for 1/2cc after sterilization: 0.85-5.95 lbs.).Data/ shield removal force: syringe 1 2.39 lbs.; syringe 2 3.43 lbs.The removal forces fall within specification.A review of the device history record was completed for batch# 9301568.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200861251, 200854826] noted that did not pertain to the complaint.Hub separates: process summary: automatic syringe assembly machine, which feeds 0.5ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Root cause: l2l dispatch #82819 was created for raised caps.There was debris collected on the dial.Corrective action: cleared the debris from the dial.Capa#1630423 was initiated.Bent cannula: reviewed dhr records, logbooks & maintenance history from sap did not find any potential causes/ adjustments to the process.There were two (2) notifications [200861251,200854826] noted that did not pertain to the complaint.Investigation: the shield misalignment on the roll-over devices, which holds the shields with the mechanical pressure is for cannula getting bent to smaller or larger angles.Root cause: no exact root cause determined.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10299067
• Report Number: 1920898-2020-00892
• Device Sequence Number: 3557480
• Product Code: FMF
• UDI-Device Identifier: 00311917025360
• UDI-Public: 00311917025360
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 10/31/2024
• Device Model Number: 928857
• Device Catalogue Number: 928857
• Device Lot Number: 9301568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 06/29/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 08/05/2020
• 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