MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
Medical Device Problem Codes	Leak/Splash (1354); Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
"date of event: unknown.The date received by manufacturer has been used.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 4 syringe 0.3ml 31ga 8mm 10bag 500 pl/wg had the following problems during use.Hub separates (2), unable to aspirate (2).The following was reported by the initial reporter: "it was reported that on 2 syringes the needle hub separated into shield.Also reported 2 other syringes would not draw up insulin.Verbatim: consumer reported found 2 syringes from this box when removed needle shield, the needle hub went with it.Consumer reported found 2 other syringes from this box when drew up insulin from vial, it would not draw up the insulin".
Event or Problem Description
It was reported that 4 syringe 0.3ml 31ga 8mm 10bag 500 pl/wg had the following problems during use.Hub separates (2), unable to aspirate (2).The following was reported by the initial reporter: "it was reported that on 2 syringes the needle hub separated into shield.Also reported 2 other syringes would not draw up insulin.Verbatim: consumer reported found 2 syringes from this box when removed needle shield, the needle hub went with it.Consumer reported found 2 other syringes from this box when drew up insulin from vial, it would not draw up the insulin".
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: 3/18/2021.H.6.Investigation: customer returned (4) 3/10cc, 8mm, 31g walgreens syringes in an open poly bag from lot # 0125322.Customer states that the needle hub separated into shield and that the syringes would not draw up insulin.All returned syringes were examined and one sample exhibited the hub-needle/shield assembly separated from the barrel.No other sample exhibited the hub assembly separated from the barrel.All remaining syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0125322.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Capa#1630423 has been opened to address this issue of needle hub separated into shield.Root cause cannot be determined at this time as syringes not drawing up insulin is unconfirmed.H3 other text : see h.10.

• Brand Name: SYRINGE 0.3ML 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: 11468117
• Report Number: 1920898-2021-00289
• Device Sequence Number: 3913110
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 04/16/2021

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: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 0125322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Received by Manufacturer: 02/12/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/11/2021
• Supplement Report FDA Received Date: 04/23/2021
• 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: Required Intervention