MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Medical device manufacture date : unknown.
Event or Problem Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle hub separated from the device.The following information was provided by the initial reporter : the consumer reported that when removing the needle shield prior to injection, the needle hub separated and was unable to use the syringe.1 syringe was affected.Date of event : (b)(6) 2021.Sample : available.
Event or Problem Description
It was reported that 1 bd insulin syringe with the bd ultra fine¿needle hub separated from the device.The following information was provided by the initial reporter : the consumer reported that when removing the needle shield prior to injection, the needle hub separated and was unable to use the syringe.1 syringe was affected.Date of event: (b)(6) 2021.Sample: available.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-13.H6: investigation summary: customer returned a single syringe in a polybag labeled for 0.3ml, 31 gauge, 8mm syringes from lot 0349902.The syringe was returned fully intact.A needle shield pull force test was performed on this syringe.The needle shield required 2.86 lbs of force to be removed.Removing the needle shield found that the hub was properly attached to the barrel of the syringe.The specification states that all pull forces within the range of 0.85 lbs to 5.95 lbs are acceptable.With the needle hub attached and the needle shield being within pull force specification, the report of the hub separating from the barrels could not be confirmed for this sample.A review of the device history record was completed for batch# 0349902.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.Based on the samples received, bd was unable to replicate or confirm the customer¿s indicated failure of needle hub separation.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12824172
• Report Number: 1920898-2021-01197
• Device Sequence Number: 19924433
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2021

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 Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2021
• Supplement Date Received by Manufacturer: 12/19/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/22/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown