MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD ULTRA-FINE 6MM¿ JERINGA PARA INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 326785

Device Problem Material Separation (1562)

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

Event Date 03/02/2024

Event Type  malfunction  

Event Description

It was reported that while using the bd ultra-fine 6mm¿ jeringa para insulina 0,3ml 31g x 6mm u-100 10x3count the needle detached from the syringe body and got stuck inside the shield.The following information was provided by the initial reporter, translated from spanish to english: detailed description of the situation: in the step to uncap the needle and attempt to twist the orange cap and remove it, the needle detached from the syringe body and got stuck inside the shield.At first glance, it can be seen that the pivot shows a deformation, below i provide the photos for a better reference.______________ did the patient require medical or surgical intervention due to the reported situation? a: no.

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H.6 investigation summary: no samples were returned therefore the investigation was performed based on the photo(s) provided.Embecta was able to confirm the customer-indicated issue.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 while using the bd ultra-fine 6mm¿ jeringa para insulina 0,3ml 31g x 6mm u-100 10x3count the needle detached from the syringe body and got stuck inside the shield.The following information was provided by the initial reporter, translated from spanish to english: detailed description of the situation: in the step to uncap the needle and attempt to twist the orange cap and remove it, the needle detached from the syringe body and got stuck inside the shield.At first glance, it can be seen that the pivot shows a deformation, below i provide the photos for a better reference.Did the patient require medical or surgical intervention due to the reported situation? a: no.

• Brand Name: BD ULTRA-FINE 6MM¿ JERINGA PARA INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18978497
• MDR Text Key: 339559119
• Report Number: 9614033-2024-00030
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326785
• Device Lot Number: 3205917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2023
• 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