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

Model Number 324910

Device Problem Inaccurate Information (4051)

Patient Problem Hypoglycemia (1912)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported when using the bd insulin syringe with the bd ultra-fine¿ needle, the device experienced scale marking issues.This event occurred 160 times.The following information was provided by the initial reporter.The customer stated: the very first scale mark (zero point) is marked the way too lower than it should be.Therefore, it makes to draw more insulin.After injection, glucose level was drop to 50mg/dl (more than usual).

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: samples were received and an investigation was performed.Bd was not able to duplicate or confirm the indicated issue hence the root cause is undetermined.Unable to perform complaint lot history check for glucose level due to unknown lot number.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: BD INSULIN SYRINGE 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13871415
• MDR Text Key: 287826571
• Report Number: 1920898-2022-00187
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249107
• UDI-Public: 00382903249107
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324910
• Device Catalogue Number: 324910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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