MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LL W/NDL 21X1-1/2 RB; PISTON SYRINGE

Catalog Number	309633
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material: 309633, batch#: 3017600.It was reported that the bd syringe 5ml ll w/ndl 21x1-1/2 rb needle hub had a hole, was cracked / damaged.The following information was provided by the initial reporter: "i don't really want to register with you, i just want to file a product.Your 5ml syringes with the green needles, product number 309633 are being produced with a flaw in the needles hub which cause them to leak.It appers to be a hole.This problem has been on-going since you stopped producing the 5ml syringe in the yellow wrapper.Yes, several lots with this flaw have left your production facility.Our current lot is 3017600.I compound hazardous drugs and i am tired of getting a shower of death every 1000 syringes, and i know others are tired of it as well.I thought that i would file a product complaint directly with you.For some reason you have decided to make this difficult to do, which is alarming because product complaint reporting is a requirement of law.I really don't want to have to complete form fda 3500 myself.Can you assure me that this email will get to the correct qa person within your company.".Item # 309633.Lot # 3017600.Additional information provided: 1.Tuesday, 21may2024.2.No evidence or photo, we compound hazardous radioactive drugs.If it happens again, we can hold it for decay and send it to you.3.No serious injury, at worst my exposure to radioactivity was increased.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
Since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 actual product involved may provide clarification as to the cause for the reported failure.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.We appreciate you taking the time to bring this observation to our attention.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 5ML LL W/NDL 21X1-1/2 RB
• Common Device Name: 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: 19515734
• Report Number: 1213809-2024-00370
• Device Sequence Number: 14995339
• Product Code: FMF
• UDI-Device Identifier: 30382903096337
• UDI-Public: (01)30382903096337(11)230117(17)271231(10)3017600
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309633
• Device Lot Number: 3017600
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown