MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 8MM; PISTON SYRINGE

Model Number 328290

Device Problems Leak/Splash (1354); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary : exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the complaint lot history check was performed and this is the 1st related complaint for leakage and for damaged (gap in syringe) on this lot #.No non-conformances were raised in association with these types of events for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.Capa/sa - based on the above no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) are required at this time.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported that 2 bd syringe 0.5ml 8mm had leakage and the hub separated.The following information was provided by the initial reporter : the consumer reported syringe leaking insulin between needle hub and barrel and stated that there appears to be a gap.Date of event : (b)(6) 2021.Samples : discarded.

• Brand Name: SYRINGE 0.5ML 8MM
• Type of Device: 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: 12444723
• MDR Text Key: 270560192
• Report Number: 1920898-2021-00973
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282906
• UDI-Public: 00382903282906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328290
• Device Catalogue Number: 328290
• Device Lot Number: 0076494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1