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

Catalog Number 328521

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Defective Component (2292)

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

Event Date 09/16/2021

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 (stopper damaged, plunger difficult to move, needle hub loose and leakage) 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 or 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 4 bd insulin syringes with the bd ultra fine¿needles had issues with deformed stoppers, plunger movement difficulty, hub separation and leakage.The following information was provided by the initial reporter : the consumer reported that the rubber stopper is larger on some of the syringes and it is difficult to move and also stated that the needle hub is loose and that the insulin is leaking between the hub and the barrel.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
• 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: 12914588
• MDR Text Key: 284386214
• Report Number: 1920898-2021-01257
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138390
• UDI-Public: 00681131138390
• 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: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/12/2021

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328521
• Device Lot Number: 0363888
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/28/2020
• 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