MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGES 3/10ML; PISTON SYRINGE

Catalog Number 328512

Device Problem Volume Accuracy Problem (1675)

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

Event Date 05/19/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 1 relion insulin syringes 3/10ml had scale marking issues.The following information was provided by the initial reporter : the consumer reported that the scale print is incorrect and stated that when the plunger rod is pushed all the way up, the stopper is above the first line.Date of event : unknown.Samples : available.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval? yes.D9: returned to manufacturer on: 31-may-2022.H6: investigation summary customer returned (3) 0.5ml syringes.Each syringe was measured using a gauge.The position of the gauge determined that the graduation markings on the syringe barrel were within specification.A review of the device history record was completed for batch# 1284104.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that did not pertain to the complaint.Based on the samples received, embecta was unable to confirm the customer¿s indicated failure of defective scale markings.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that 1 relion insulin syringes 3/10ml had scale marking issues.The following information was provided by the initial reporter : the consumer reported that the scale print is incorrect and stated that when the plunger rod is pushed all the way up, the stopper is above the first line.Date of event : unknown.Samples : available.

• Brand Name: RELION INSULIN SYRINGES 3/10ML
• 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: 14707792
• MDR Text Key: 296059200
• Report Number: 1920898-2022-00386
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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: 1284104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2021
• 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