MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD MICRO-FINE¿+ DEMI INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 324826

Device Problem Separation Problem (4043)

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

Event Date 01/13/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger pulled out of the bd micro-fine¿+ demi insulin syringe when attempting to remove the cap.The following information was provided by the initial reporter, translated from german: "when the customer pulls off the lower cap, not only does the cap come off, but she also pulls out the plunger of the syringe.".

Manufacturer Narrative

H6: investigation summary; no samples were returned therefore the investigation was performed based on the photos provided.The customer returned two photos of the 30gx8mm bd syringes.The customer reported that when the lower cap is pulled off, not only does the cap come off, but she also pulls out the plunger of the syringe.Furthermore, the cap is firmly connected to the syringe plunger, but cannot be released.The photo was observed, and displays a single syringe without any packaging, lying flat and dismantled with the plunger rod lying next to the barrel with the cap still attached.A review of the device history record was completed for batch# 2045463.All inspections and challenges were performed per the applicable operations qc specifications.Embecta was able to duplicate or confirm the customer¿s indicated failure based on the photo received.The root-cause could not be determined.H3 other text : see h10.

Event Description

It was reported that the plunger pulled out of the bd micro-fine¿+ demi insulin syringe when attempting to remove the cap.The following information was provided by the initial reporter, translated from german: "when the customer pulls off the lower cap, not only does the cap come off, but she also pulls out the plunger of the syringe.".

• Brand Name: BD MICRO-FINE¿+ DEMI INSULIN SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16301157
• MDR Text Key: 308872433
• Report Number: 1920898-2023-00037
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324826
• Device Lot Number: 2045463
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2022
• 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