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

Catalog Number 328512

Device Problem Defective Component (2292)

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

Event Date 03/04/2023

Event Type  malfunction  

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.

Event Description

It was reported that 20 8mm relion® insulin syringes had cannulas shorter than 8mm.The following information was provided by the initial reporter: consumer reported finding the needles appear to be shorter than 8mm.Box and bag says 8mm though.When did the incident occur?: before use.Death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first aid: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no.

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 : customer returned (3) 0.3ml 31ga 8mm syringes in an open polybag from the lot#2290537.It was reported by the customer that they are finding needles appearing to be shorter than 8mm box.The returned samples were measured for cannula length using comparator and all the needles cannula length was measured within the specified acceptance limits (+/- 0.047).Hence, the alleged issue could not be confirmed based on the samples return.A review of the device history record was completed for batch # 2290537 all inspections were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to confirm the customer indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that 20 8mm relion® insulin syringes had cannulas shorter than 8mm.The following information was provided by the initial reporter: "consumer reported finding the needles appear to be shorter than 8mm.Box and bag says 8mm though.When did the incident occur?: before use death?: no.Serious injury: no.Erroneous results: no.Course treatment changed due to event: no.Exposure to blood/bodily fluid: no.Medical intervention other than first a.Id: no.Needle/probe stick: no.Safety issue: no.Other actions taken: no".

• 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 ; 8448235433
• MDR Report Key: 16716464
• MDR Text Key: 313158592
• Report Number: 1920898-2023-00213
• 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
• Report Date: 07/13/2023

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: 03/22/2023
• Initial Date FDA Received: 04/11/2023
• Supplement Dates Manufacturer Received: 07/13/2023
• Supplement Dates FDA Received: 07/27/2023
• 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