MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 12.7MM (1/2") 30G; PISTON SYRINGE

Model Number	328431
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that while using a bd insulin syringes with bd ultra-fine¿ needle 3/10ml 12.7mm (1/2") 30g u-100 100 count, the needle breaks off in the vial.The following information was provided by the initial reporter: "needles are falling out of syringes".Consumer stated, when drawing insulin, the needle only, will break off in vial.
Event or Problem Description
It was reported that while using a bd insulin syringes with bd ultra-fine¿ needle 3/10ml 12.7mm (1/2") 30g u-100 100count, the needle breaks off in the vial.The following information was provided by the initial reporter: "needles are falling out of syringes".Consumer stated, when drawing insulin, the needle only, will break off in vial.
Additional Manufacturer Narrative
H6: investigation summary: customer returned (1) loose 0.3ml bd insulin syringe.The customer reported that the needle will break off in the vial.The returned sample was examined, and it was observed that the cannula was undamaged.The sample was tested for point geometry, outer diameter and lube coverage (specs: outer diameter for 30g cannula: 0.0120¿- 0.0125¿) and it was observed that the sample measured within specification at 0.0123¿ and exhibited good point geometry and sufficient lube coverage.No defects compromising the cannula integrity were observed.The alleged issue could not be confirmed based on the sample returned.Due to the batch being unknown, no dhr review can be completed.Embecta was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 3/10ML 12.7MM (1/2") 30G
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15187815
• Report Number: 1920898-2022-00528
• Device Sequence Number: 5807732
• Product Code: FMF
• UDI-Device Identifier: 00382908431033
• UDI-Public: 00382908431033
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 328431
• Device Catalogue Number: 328431
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 08/08/2022
• Supplement Report FDA Received Date: 09/01/2022
• 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