MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SFTYGLD 23X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
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 #:305902; batch#:4095458.It was reported that the bd needle sftygld 23x1 rb leaked.The following information was provided by the initial reporter: verbatim: while administering depo injection, medication began to leak from hub where needle was inserted into syringe, even though it was screwed in tightly and correctly.305902 also attached lot # 4095458.Additional information provided: 1.Please confirm the affected batch# or lot# number is 4095458? also another lot was mentioned in bd pir.Please confirm any issue with this lot# number 4116045? if any issue with this lot# number 4116045, what was the issue with this.Given this occurred between the syringe and the needle, the reporter gave both lot numbers.The other lot number is apparently from the 3 ml syringe- also a bd product 2.If sample available, kindly provide the address of the facility for us to ship the return label.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - leakage.One sample was provided to our quality team for investigation.A visual inspection was performed, and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution, no leakage was observed.The solution was expelled through the needle tip with normal flow.Furthermore, a device history record review was completed for provided lot number 4095458.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.Based on the investigation and with the sample analysis the symptom reported could not be confirmed.

• Brand Name: BD NEEDLE SFTYGLD 23X1 RB
• 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: 20424267
• Report Number: 1213809-2024-00697
• Device Sequence Number: 8506363
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028(11)240404(17)290331(10)4095458
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2024

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: 305902
• Device Lot Number: 4095458
• 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: 09/18/2024
• Supplement Date Received by Manufacturer: 12/11/2024
• Initial Report FDA Received Date: 10/10/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown