MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE; PISTON SYRINGE

Catalog Number 328512

Device Problem Material Separation (1562)

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

Event Date 07/18/2023

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 relion® insulin syringe needle separated from the hub and got stuck in the shield while trying to remove the shield.The following information was provided by the initial reporter: "consumer is reporting two issues from her box.Stated, she could not remove the needle shield prior to injection from one syringe therefore she is not able to use syringe stated, with a second syringe, when she removed the needle shield, the needle got stuck inside the shield.".

Manufacturer Narrative

H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 2290537.All inspections and challenges were performed per the applicable operations qc specification.H3 other text : see h10.

Event Description

It was reported that the relion® insulin syringe needle separated from the hub and got stuck in the shield while trying to remove the shield.The following information was provided by the initial reporter: "consumer is reporting two issues from her box.Stated, she could not remove the needle shield prior to injection from one syringe therefore she is not able to use syringe stated, with a second syringe, when she removed the needle shield, the needle got stuck inside the shield.".

Event Description

It was reported that the relion® insulin syringe needle separated from the hub and got stuck in the shield while trying to remove the shield.The following information was provided by the initial reporter: "consumer is reporting two issues from her box.Stated, she could not remove the needle shield prior to injection from one syringe therefore she is not able to use syringe stated, with a second syringe, when she removed the needle shield, the needle got stuck inside the shield.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-nov-2023.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: RELION® 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17480901
• MDR Text Key: 320615992
• Report Number: 1920898-2023-00531
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328512
• Device Lot Number: 2290537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 07/18/2023
• Initial Date FDA Received: 08/08/2023
• Supplement Dates Manufacturer Received: 09/07/2023; 11/09/2023
• Supplement Dates FDA Received: 09/25/2023; 11/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2022
• 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