MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number 309626

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that the bd syringe 1ml s/t w/ndl 25x5/8 rb needle went through the shield.The following information was provided by the initial reporter: it was reported by customer that we keep finding needles that are bent and sticking out of the caps that jab us when we open them (clearly a manufacturing problem with poor quality control, but a major safety issue!) label stickers do not stick to these syringes because they are coated in something slippery, so it makes it very challenging to label substances in them when we draw up injections and we are terrified it could result in giving the wrong injections, so it has really destroyed our usual surgery day flow because we cannot safely draw up all injections ahead of time for small patients needles don't stay on the end of these at all! just this morning, i doused myself, my assistant, and an owner in euthanasia solution when i attempted to euthanize a rat.We all got fatal plus in our mouths and eyes.Obviously, this not only is a huge liability, but it is costing me a ton of money in injectable medications that have to be drawn up again when they leak out of faulty syringes and puts pets at risk of overdose because sometimes they get some of the injection and we don't know how much to give when we re-dose.I appreciate you - this is not in anyway an upset with midwest, but i did want to communicate with you my concerns about this terrible syringes! have a wonderful week! (b)(6).Verbatim: i just wanted to alert you to a product issue.Bd 1 ml tb syringes slip tip with bd precisionglide needle 25g x 5/8" our issues with them range from: we keep finding needles that are bent and sticking out of the caps that jab us when we open them (clearly a manufacturing problem with poor quality control, but a major safety issue!) label stickers do not stick to these syringes because they are coated in something slippery, so it makes it very challenging to label substances in them when we draw up injections and we are terrified it could result in giving the wrong injections, so it has really destroyed our usual surgery day flow because we cannot safely draw up all injections ahead of time for small patients needles don't stay on the end of these at all! just this morning, i doused myself, my assistant, and an owner in euthanasia solution when i attempted to euthanize a rat.We all got fatal plus in our mouths and eyes.Obviously, this not only is a huge liability, but it is costing me a ton of money in injectable medications that have to be drawn up again when they leak out of faulty syringes and puts pets at risk of overdose because sometimes they get some of the injection and we don't know how much to give when we re-dose.I appreciate you - this is not in anyway an upset with midwest, but i did want to communicate with you my concerns about this terrible syringes! have a wonderful week! (b)(6), dvm.

Event Description

No additional information.

Manufacturer Narrative

(b)(4): follow up mdr for device evaluation.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 25X5/8 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18924441
• MDR Text Key: 337911579
• Report Number: 1213809-2024-00168
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: (01)30382903096269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309626
• Device Lot Number: 3212498
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1