MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 305109

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

A broken hub.

Manufacturer Narrative

(b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.

Event Description

No additional information received.A broken hub.White coloured solids found on needle.

Manufacturer Narrative

Pr (b)(4) follow up for device evaluation.It was reported there was a broken hub and white colored solids found on needle.To aid in the investigation, one sample in an opened packaging blister from lot 1335527.A visual inspection was performed.No damages of and kind were observed and there is no epoxy on the needle.There is an epoxy drip over on the needle hub.No other defects or imperfections were observed.The epoxy drip over can occur if there was a jam at the cannulator.A device history record review was completed for provided material number 305109, lot 1335527.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer of epoxy is confirmed.

• Brand Name: NEEDLE 27X1/2 RB
• Type of Device: 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: 18684899
• MDR Text Key: 335117415
• Report Number: 1911916-2024-00078
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051091
• UDI-Public: (01)30382903051091
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/02/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 305109
• Device Lot Number: 1335527
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 03/02/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1