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

Catalog Number	305197
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 305197, batch# 3320201.It was reported by customer that damaged needles verbatim: damaged needles (broken, had bent tips, and had damage to the middle of the needle.).
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
Pr 10242361 follow up for device evaluation.It was reported the needles had bent tips and had damage to the middle of the needle.To aid in the investigation, eight hundred forty-one samples in sealed packaging blisters and three photos were received for evaluation by our quality team.Eighty samples were randomly selected for investigation.A visual inspection was performed with a 30x microscope.There was no damage, defective grind or hooks observed.The bevels and etch were good.The needle hubs did not have any type of damage.In the photos provided, one photo shows a packaging shelf box, one photo shows a packaging blister top web, and the third photo shows a needle assembly with no packaging blister or plastic shield.The needle hub is damaged, broken in two pieces.No other information could be obtained from the photos.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.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.Without the actual defective physical sample analysis, a probable root cause could not be offered.
Event or Problem Description
Additional information received.[1] date of event: several times over the last several weeks- 5/6/2024 thru 5/23/2024 [2] adverse events because of defect: several medications were ¿sprayed¿ on technicians and work deck when needle broke.One technician stuck her finger when attempting to puncture a medication vial.An incident report was documented.[3] *the needles in question have been breaking in the middle of the plastic hub.Some have a small indentation in the middle of the needle section and some have a fish hook appearance at the very tip of the needle.Material# 305197 batch# 3320201.It was reported by customer that damaged needles.Verbatim: damaged needles (broken, had bent tips, and had damage to the middle of the needle.).

• Brand Name: NEEDLE 16X1 RB
• 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: 19433749
• Report Number: 1911916-2024-00391
• Device Sequence Number: 8299150
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 06/14/2024

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: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2024
• Supplement Date Received by Manufacturer: 06/14/2024
• Initial Report FDA Received Date: 05/31/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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