MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27GA 1-1/2IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	301629
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2024
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 # 301629 batch # unknown.It was reported by customer that when the radiologists was using the leurlok needle, the needle snapped off while it was twisted onto the syringe.Rcc received a complaint via email.Chc complaint reference #: (b)(4), hospital complaint reference #: (b)(4), customer (hospital) name: xxxxx, customer address: xxxxx, contact name: xxxxx, phone: xxxxx, e-mail: xxxxx.Correspondence language: english, cat# of product being complained: bd301629, description of product: needle prec glide 27gx1 1/2in 100ea/bx 10bx/ca, lot or s/n: (b)(6), complaint category: damaged / broken, reportable: no, incident date: on (b)(6) 2024, hospital complaint reference #: (b)(4).Details of complaint (reported issue): "when the radiologists was using the leurlok needle, the needle snapped off while it was twisted onto the syringe.No contact with the patient." additional information will be sent via separate email.Complaint noticed: during / after use problem frequency: 1st time.
Additional Manufacturer Narrative
Pr (b)(4) follow up.A device history record review was completed by our quality engineer team for provided material number 301629 and lot number 4050660.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.Batch 4050660.

• Brand Name: NEEDLE 27GA 1-1/2IN
• 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: 20639557
• Report Number: 1911916-2024-00796
• Device Sequence Number: 7432258
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: (01)30382903016298(11)240219(17)290331(10)4050660
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: Health Professional
• Device Catalogue Number: 301629
• Device Lot Number: 4050660
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown