MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 25X5/8 RB; PISTON SYRINGE

Catalog Number	309570
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 309570, batch # 1161233.It was reported that the bd syringe 3ml ll w/ndl 25x5/8 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Needle comes off of syringe item(s): 309570, lot(s): 1161233.Date incident occurred: on going was the patient impacted? yes, needle comes off of syringe if yes, describe: 3 bottles of b12 wasted is a sample available?: yes.Customer request?: needing reimbursement for syringes and b12.Customer response on (b)(6) 2025.That¿s what you call really bad multi-tasking.Sorry.Yes, i was waiting for you to contact me about the bad syringes and the loss of three bottle so my b12 serum, which is costly.The bad syringes occurred on these dates: (b)(6) 24 and (b)(6) 2025.I did not get a shipping label and i¿m not sure what you want me to return.I discarded two of the three bad syringes.I have the open and now useless b12 bottles and two of the pharmacy bottles.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
One sample was provided to our quality team for investigation.A visual inspection was performed with 30x magnification no defects or imperfections were observed.The sample was assembled to a syringe with saline solution.The solution was expelled with no issued observed.Based on the investigation and with the sample analysis the symptom reported could not be confirmed.Furthermore, a device history record review was completed for provided lot number 1161233.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.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 3ML LL W/NDL 25X5/8 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: 21211771
• Report Number: 1213809-2025-00020
• Device Sequence Number: 8070458
• Product Code: FMF
• UDI-Device Identifier: 30382903095705
• UDI-Public: (01)30382903095705(11)210610(17)260531(10)1161233
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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: Other
• Device Expiration Date: 05/31/2026
• Device Catalogue Number: 309570
• Device Lot Number: 1161233
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2025
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 01/22/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown