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

Catalog Number 324916

Device Problem Leak/Splash (1354)

Patient Problems Hematoma (1884); Hyperglycemia (1905); Pain (1994)

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 bd ultra-fine¿ insulin syringe was blocked.The following was translated from portuguese to english: i used the syringe, bd ultra-fine insulin syringe 6mm 30ui yesterday and when i went to apply it, it wouldn't go into my skin.When it did, it hurt me, blood came out and all the insulin leaked out.Additional information received 6.Dec.2023.What is the batch and catalog of the product? 2304334 a syringe ultra fine bd 6mm 30ui.Could you share the patient's condition? it cut my skin, the insulin leaked out and as a result my blood sugar went up too much.What security measures are taken after the incident? skin all bruised, cut and leaking blood from the insulin.Was there a need for medical and/or surgical intervention due to the incident (imaging exams, surgery, medication administration, etc.)? (detail) high blood sugar :364.Is the incident-related sample available for analysis? if so, how many units? yes, there is 1 unit.Has anvisa already been notified? if so, what was the notification number? what about me making the notification? a: no.

• Brand Name: BD ULTRA-FINE¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18389175
• MDR Text Key: 331493184
• Report Number: 1920898-2023-00846
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324916
• Device Lot Number: 2304334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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