MAUDE Adverse Event Report: BD SYRINGES

Model Number TB

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Filling Problem (1233)

Patient Problems Bruise/Contusion (1754); Swelling (2091)

Event Date 03/02/2014

Event Type  malfunction  

Event Description

I began a round of allergy injections which the doctor deemed that i, as a long term diabetic, would be qualified in handling at home.I purchased on prescription from (b)(4) pharmacy #(b)(4) bd1ml tb syringes and attempting to use them found them impossible to fill without including air in the syringe.I injected the first set from the allergy vials and true to use, had bruising and lumps in the skin at the injection sites ((b)(6)2014).Assuming i had done something wrong (despite over 20 years of both injection into fat and muscle) i dismissed the problem initially.On attempting to draw down the second set on (b)(6) 2014, i found out why when attempting to fill the first syringe, the needle end of the syringe fell out.The end with the plug and inserted needle is not manufactured to seal and are setting in place only with a pressure fit (pushed into place).Because of that fit it is impossible to draw down any amount over.5 ml without also drawing a bubble into the syringe.At this point, i grabbed my own bd ultra-fine ii insulin syringes to check "correct" manufacture and found it positively impossible to remove the needle from the syringe barrel.It is either glued or otherwise fix (such as a heat seal in manufacture, etc) in place and cannot be removed (unlike the tb's) this side of breaking the syringe (using a pair of pliers crushed the syringe before any parting of any kind would allow air into the syringe barrel through the same area).I know darned well what happens if someone injects air bubbles into the body and i'm sure that it would be possible for someone to end up dead if they hit an artery and even damage would be possible hitting a vein.

• Brand Name: SYRINGES
• Type of Device: SYRINGES
• Manufacturer (Section D): BD
• MDR Report Key: 3672551
• MDR Text Key: 18869230
• Report Number: MW5034865
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TB
• Device Catalogue Number: 4219
• Device Lot Number: 309623
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 91