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
Event or Problem Description
It was reported by customer that 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.Verbatim: rcc received a complaint via email.Email(s) attached component description: bd syringe: needle 23x 1-1/2.Bd catalogue: 3320231 exp.01/2029 inv due: 21nov2024.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
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 305194 and lot number 3320231.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
Additional information received.1.When was this defect observed? during or before use? the defect was observed during use.2.What was the impact to the patient? patient did not miss dose due to this defect.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.None reported.

• 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: 20577529
• Report Number: 1911916-2024-00779
• Device Sequence Number: 20962684
• 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): 11/04/2024

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: 305194
• Device Lot Number: 3320231
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 10/31/2024
• Supplement Report FDA Received Date: 11/04/2024
• 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