MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305194
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material #: 305194; batch#: 3320231.It was reported by customer that patient reported to specialty pharmacy on (b)(6) 2024.Patient opened secure cap from diluent syringe and attached needle.Upon pushing down on plunger the liquid leaked out from the junction between the syringe the needle.Patient experienced this same issue 2 more times before she got one to work.Gattex dose not missed.Patient has been taking gattex for over 7 years.This issue has not occurred again since the day this happened this month.Verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached external evaluation is required for pr# (b)(4) ¿ leaking.Product: gattex ; component description: bd syringe: needle 23x 1-1/2; bd catalogue: 3320231 exp.01/2029; inv due: (b)(6) 2024.Report received from pv on 11oct2024: patient reported to specialty pharmacy on (b)(6) 2024.Patient opened secure cap from diluent syringe and attached needle.Upon pushing down on plunger the liquid leaked out from the junction between the syringe the needle.Patient experienced this same issue 2 more times before she got one to work.Gattex dose not missed.Patient has been taking gattex for over 7 years.This issue has not occurred again since the day this happened this month.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was determined that this complaint is a duplicate of (b)(4) and the complaint will be cancelled.The associated mdr will be void.
Event or Problem Description
Following the submission of the initial mdr, it was determined that this complaint is a duplicate of (b)(4) and the complaint will be cancelled.The associated mdr will be void.

• Brand Name: NEEDLE 23X1-1/2 RB TW
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20544379
• Report Number: 1911916-2024-00765
• Device Sequence Number: 20697978
• Product Code: FMI
• UDI-Device Identifier: 30382903051947
• UDI-Public: (01)30382903051947(11)231116(17)290131(10)3320231
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 11/13/2024

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: Lay User/Patient
• Device Catalogue Number: 305194
• Device Lot Number: 3320231
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/28/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown