MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 31GA 6MM U40; PISTON SYRINGE

Catalog Number 324902

Device Problem Leak/Splash (1354)

Patient Problems Hematoma (1884); Pain (1994)

Event Date 08/08/2020

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.(b)(4).

Event Description

It was reported that the plunger is difficult to move during injection with 10 bd syringe 1.0ml 31ga 6mm u40.The following information was provided by the initial reporter: insulin syringes that are hard to inject.I have been using bd insulin syringes 31g for long time.But of late i am finding quality has come down.They are very tight and hard.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/5/2020.H.6.Investigation: customer returned (19) 1cc, 6mm, 31g u40 insulin syringes (9 in an open poly bag, 10 in a sealed poly bag) with the shelf carton from lot # 9231170.Customer states that the syringes are hard to inject, they are very tight, and they need a lot of energy for injecting which causes pain, hardship and at times bleeding.All returned syringes were tested (#1-9 from the open poly bag, #10-19 from the sealed poly bag) for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications.Also, all samples were tested and all were able to draw and expel properly without any observed defects.All observations fall within specifications.A review of the device history record was completed for batch# 9231170.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200842457] noted that did not pertain to the complaint.There was one (1) notification [200841002] noted for out of spec breakout and sustaining.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

Event Description

It was reported that the plunger is difficult to move during injection with 10 bd syringe 1.0ml 31ga 6mm u40.The following information was provided by the initial reporter: insulin syringes that are hard to inject.I have been using bd insulin syringes 31g for long time.But of late i am finding quality has come down.They are very tight and hard.

• Brand Name: BD SYRINGE 1.0ML 31GA 6MM U40
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10463458
• MDR Text Key: 206348698
• Report Number: 1920898-2020-01123
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324902
• Device Lot Number: 9231170
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 08/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other