MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number 305197

Device Problem Break (1069)

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

Event Date 03/06/2024

Event Type  malfunction  

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.H3 other text : see h10 manufacture narrative.

Event Description

Material #: 305197 batch#: 3320201 it was reported by customer that mat# 305197 lot 3320201 several needles were bent and sometimes when they try to unscrew the needles it snaps from the hub.Customer has 5 boxes sequestered.Date of event march 6th, no pt harm occurred.Verbatim: complaint received via email(s) attached.Customer called to report that mat# 305197 lot 3320201 several needles were bent and sometimes when they try to unscrew the needles it snaps from the hub.Customer has 5 boxes sequestered.Date of event march 6th, no pt harm occurred.

Event Description

No additional information received.Material #: 305197.Batch#: 3320201.It was reported by customer that mat# 305197 lot 3320201 several needles were bent and sometimes when they try to unscrew the needles it snaps from the hub.Customer has 5 boxes sequestered.Date of event march 6th, no pt harm occurred.Verbatim: complaint received via email(s) attached.Customer called to report that mat# 305197 lot 3320201 several needles were bent and sometimes when they try to unscrew the needles it snaps from the hub.Customer has 5 boxes sequestered.Date of event march 6th, no pt harm occurred.

Manufacturer Narrative

Pr 9889703 follow up for device evaluation.It was reported several needles were bent and sometimes when they try to unscrew the needles it snaps from the hub.To aid in the investigation, three hundred fifty-seven samples in sealed packaging blisters were received for evaluation by our quality team.One hundred twenty-five samples were randomly selected for investigation.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed.Each sample was then assembled and disassembled to a syringe with saline solution with no issues or leakage was observed.A device history record review was completed for provided material number 305197, lot 3320201.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.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 could not be confirmed.

• Brand Name: NEEDLE 16X1 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: 18960614
• MDR Text Key: 338376361
• Report Number: 1911916-2024-00208
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

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: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/22/2024
• Supplement Dates Manufacturer Received: 04/09/2024
• Supplement Dates FDA Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1