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

Model Number	328411
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 the bd insulin syringes with bd ultra-fine¿ needle 1ml 12.7mm (1/2") 30g product is damaged.The following information was provided by the initial reporter: one of the syringes was sticking out of the box and the barrel was bent.
Event or Problem Description
It was reported that the bd insulin syringes with bd ultra-fine¿ needle 1ml 12.7mm (1/2") 30g product is damaged.The following information was provided by the initial reporter: one of the syringes was sticking out of the box and the barrel was bent.
Additional Manufacturer Narrative
Investigation summary: customer returned (2) loose 1ml bd insulin syringes.The following was reported: two extra syringes that were loose inside of the box; one of the syringes was sticking out of the box and the barrel was bent; there was no issue with the other syringe; there were 10 sealed bags in the box along with the 2 loose syringes.The samples were examined, and it was observed that 1 syringe featured a bowed barrel.No defects were observed on the remaining sample, and no packaging was returned.A review of the device history record was completed for batch# 1347550.All inspections were performed per the applicable operations qc specifications.Embecta was able to confirm the customer¿s indicated failure.No root cause can be determined at this time.

• Brand Name: BD INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE 1ML 12.7MM (1/2") 30G
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 15199058
• Report Number: 1920898-2022-00535
• Device Sequence Number: 14016337
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K190054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2022

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: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 1347550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2022
• Supplement Date Received by Manufacturer: 08/15/2022
• Initial Report FDA Received Date: 08/10/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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