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

Catalog Number 324916

Device Problem Failure to Deliver (2338)

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 unspecified bd ¿ 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 (b)(4) unit.Has anvisa already been notified? if so, what was the notification number? what about me making the notification?: a: no.

Manufacturer Narrative

The following fields have been updated due to additional information: d4.Medical device catalog #: 324916.D4.Medical device lot #: 2304334.D4.Medical device expiration date: 30nov2027.D4.Unique identifier (udi) # (b)(4).D4.Medical device manufacture: bd medical - diabetes care.H4.Device manufacture date: 31oct2022.

Event Description

It was reported that the unspecified bd ¿ 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.

Manufacturer Narrative

H.6.Investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was not able to confirm the customer-indicated issue as no evidence related to the reported failure was observed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

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.

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.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes/ no.D9: returned to manufacturer on: 20feb2024.H.6.Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.

• 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): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18376460
• MDR Text Key: 331379796
• Report Number: 2243072-2023-02222
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: UNKNOWN
• 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,Followup,Followup,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 3204334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2022
• 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