MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN

Catalog Number 328820

Device Problem Break (1069)

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

Event Date 09/10/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that syringe 1.0ml 31ga 8mm tw 10bag 500 twn cannula broke.This occurred on 80 occasions.The following information was provided by the initial reporter: call received from the customer who has been injecting insulin for his diabetes for a number of years.Customer has been using the bd 8mm syringe, the previous box used was 30gx8mm, with this product the customer had no issues with injecting.The current box is 31gx8mm, with this box of product, customer has reported that the needles regularly break when he is using them to inject, and most of the time when he goes to insert the needle into the cartridge to withdraw his dose he has been having lots of issues like the needle struggles to insert through the cartridge end, at times the needle has broken when trying to insert to withdraw dose.The customer confirmed that he uses a new syringe for every injection, and the injections are of protophane twice a day.

Manufacturer Narrative

Investigation summary: customer returned (10) 31gx8mm bd insulin syringes in an unopened polybag from lot# 8127851.The customer reported that the needles regularly bend and break when he is using them to inject, and the needle is blunt.All 10 returned syringes were examined, then tested for point geometry, outer diameter and lube coverage.The following was observed (specs: outer diameter for 31g cannula: 0.0100¿- 0.0105¿): data: point outer diameter (in.) lube sample (b)(6) : good, 0.0103, good; sample (b)(6) : good, 0.0103, good; sample (b)(6) : good, 0.0103, good; sample (b)(6) : good, 0.0103, good; sample (b)(6) : good, 0.0103, good; sample (b)(6): good, 0.0103, good; sample (b)(6): good, 0.0103, good; sample (b)(6): good, 0.0103, good; sample (b)(6): good; 0.0103, good; sample (b)(6): good, 0.0103, good.All observations fell within specification.None of the examined syringes exhibited a bent, broken, or blunt cannula.No evidence of manufacturing defect was observed.Since no defects were observed, the alleged issues could not be confirmed.A review of the device history record was completed for batch # 8127851.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications noted that did not pertain to the complaint.Bd was not able to duplicate or confirm the customer¿s indicated failure.

Event Description

It was reported that syringe 1.0ml 31ga 8mm tw 10bag 500 twn cannula broke.This occurred on 80 occasions.The following information was provided by the initial reporter: call received from the customer who has been injecting insulin for his diabetes for a number of years.Customer has been using the bd 8mm syringe, the previous box used was 30gx8mm, with this product the customer had no issues with injecting.The current box is 31gx8mm, with this box of product, customer has reported that the needles regularly break when he is using them to inject, and most of the time when he goes to insert the needle into the cartridge to withdraw his dose he has been having lots of issues like the needle struggles to insert through the cartridge end, at times the needle has broken when trying to insert to withdraw dose.The customer confirmed that he uses a new syringe for every injection, and the injections are of protophane twice a day.

• Brand Name: SYRINGE 1.0ML 31GA 8MM TW 10BAG 500 TWN
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12601655
• MDR Text Key: 276615824
• Report Number: 1920898-2021-01059
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 328820
• Device Lot Number: 8127851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2018
• 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