MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 SYRINGE 1.0ML 27GA 5/8IN 10BAG 500 BDD; SYRINGE, PISTON

Model Number	329412
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : device is not available.
Event or Problem Description
A pharmacy technician was dispensing product (b)(6) - lot 309 3588, caused a needle stick due to either the cap missing or the cap malfunctioning.The needle stick was a clean stick and the technician checked the rest of the needles and no others were missing the caps.
Additional Manufacturer Narrative
Additional information provided to sections.Corrections made to section h6 (component code, type of investigation, & investigation conclusions).Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed, and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: SYRINGE 1.0ML 27GA 5/8IN 10BAG 500 BDD
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
• Manufacturer (Section G): BECTON, DICKINSON & CO.; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19067900
• Report Number: 1920898-2024-05077
• Device Sequence Number: 12229964
• Product Code: FMF
• UDI-Device Identifier: 30382903294122
• UDI-Public: 30382903294122
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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: Health Professional
• Device Model Number: 329412
• Device Lot Number: 3093588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown