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

Model Number 328468

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/30/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 syringes plunger rod was difficult to move.This is 2 of 2 related events.The following information was provided by the initial reporter: consumer reported that there is liquid in the syringes, he stated that when depresses the plunger rod, liquid comes out of the syringe.Consumer also reported that the plunger rod is difficult to move.

Event Description

It was reported that the relion insulin syringes plunger rod was difficult to move.This is 2 of 2 related events.The following information was provided by the initial reporter: consumer reported that there is liquid in the syringes, he stated that when depresses the plunger rod, liquid comes out of the syringe.Consumer also reported that the plunger rod is difficult to move.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 08-may-2023.H6: investigation summary: the customer returned (1) 0.5ml 31ga 8mm syringe, reporting plunger difficult to move.The syringe was visually inspected and observed no physical damages.A functionality test was performed on the plunger, and no issues related to the plunger being difficult to move were observed.Based on the sample returned, embecta was not able to confirm the customer-indicated failure.A review of the device history record was completed for batch# 2213872.All inspections and challenges were performed per the applicable operations qc specifications.The root cause cannot be determined, as the reported failure could not be confirmed.H3 other text : see h10.

• Brand Name: RELION INSULIN SYRINGES
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16773333
• MDR Text Key: 313947207
• Report Number: 1920898-2023-00242
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: (01)00382908468039
• 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: 07/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: 2213872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2022
• 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