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

Catalog Number 328520

Device Problems Break (1069); Complete Blockage (1094)

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

Event Date 03/25/2022

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 syringe had product damage issues.The following information was provided by the initial reporter: the consumer stated some syringes will not draw insulin and flanges broken off the barrel.Date of event: unknown.Samples: available.

Event Description

It was reported that 1 relion insulin syringe had product damage issues.The following information was provided by the initial reporter : the consumer stated some syringes will not draw insulin and flanges broken off the barrel.Date of event : unknown.Samples : available.

Manufacturer Narrative

The following fields were updated due to additional information: d.4.Medical device lot #: 1298598.D.4.Medical device expiration date: 30-nov-2026.H.4.Device manufacture date: 25-nov-2021.D.4.Medical device lot #: 1032963.D.4.Medical device expiration date: 28-feb-2026.H.4.Device manufacture date: 01-feb-2021.D.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12-apr-2022.H.6.Investigation: customer returned a total of 101 syringes.1 was returned loose and the remaining 100 were returned in a shelf carton in unopened polybags labeled for 0.5ml, 31 gauge, 6mm syringes from lot 1032963.The loose syringe was visually inspected and no defects were found.The needle was unbent and the flanges were undamaged.Functional testing the syringe found that the needle was obstructed.A rod was inserted into the cannula of the needle and an obstruction was encountered, but could not be dislodged.30 of the remaining syringes were inspected and no defects were found.Both the needles and the flanges were undamaged.Functional testing of the syringes found no issues with drawing and expelling water from the syringe barrel.All syringes were undamaged and functioned as intended.A review of the device history record was completed for batch# 1032963.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.A review of the device history record was completed for batch# 1298598.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Based on the samples received, embecta was able to confirm the customer¿s indicated failure of the syringe not drawing as the result of an obstruction in the needle.No root cause can be determined at this time.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14166569
• MDR Text Key: 289736635
• Report Number: 1920898-2022-00263
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138376
• UDI-Public: 00681131138376
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• 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: 05/23/2022

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: 328520
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/21/2022
• Supplement Dates Manufacturer Received: 05/13/2022
• Supplement Dates FDA Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2021
• 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