MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 25X5/8 RB MCK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	306609
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle sftygld 25x5/8 rb mck needle pulled out of the hub.The following information was provided by the initial reporter: material # 306609 batch # 5016206.Rcc received a complaint via email.Complaint number (b)(4), report date (b)(6) 2025, factory/manufacturer bd, mfr reorder # 192-n2558s, product name - needle, sfty 192-n2558s prevent sg org 25gx5/8".Needle detached from hub and was left in patient.We had an incident with a needle yesterday.A baby was given a vaccine and when the nurse pulled back the needle, the needle stayed in the baby¿s leg completely disconnected from the syringe.Thankfully the nurse was able to remove the needle with tweezers so no injury was noted for the child.The needles /syringe is lot # 5016206.We have currently 10 boxes of this lot that i had staff pull.I have included the image additional information provided: 1.Kindly provide the date of event.08 may 2025.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event negative outcome - slowed down our production.- no injuries noted.
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
(b)(6) - supplemental mdr - needle pulled out of hub.A total of 2,393 samples were received for evaluation.From these, 500 samples were randomly chosen for visual inspection, and no defects or issues were found.Out of those 500 samples, 80 samples were further selected for cannula pull force testing, and all results met the required specifications.One photo was also provided, showing a syringe with a needle assembly.In the image, the needle is separated from the hub and placed next to the syringe.Based on this photo, the reported issue was confirmed.Furthermore, a device history record review was completed for provided lot number 5016206.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SFTYGLD 25X5/8 RB MCK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 22119027
• Report Number: 1213809-2025-00360
• Device Sequence Number: 12500308
• Product Code: FMI
• UDI-Device Identifier: 10612479262567
• UDI-Public: (01)10612479262567(11)250116(17)291231(10)5016206
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 306609
• Device Lot Number: 5016206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2025
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 06/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown