MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Materials#: 305195 batch#: 2363714 it was reported by the customer that coring is occurring when they are inserting in medication vials.Rcc received a complaint via phone.Pir attached.Product complaint-mds facility: (b)(6) ref: 305196 ref 305196 lot: 2nd 3271842 issue: coring is occurring when they are inserting in medication vials.Doe: unknown pt harm: no sample: representative samples available this case is related to (b)(4) when this gets transitioned into tw please relate the cases.
Additional 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.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation; it was reported coring is occurring when inserting into medication vials.To aid in the investigation, one sample in a sealed packaging blister was received for evaluation by our quality team.A visual inspection was performed with a 30x microscope.There was no damaged, defective grind or hooks observed.The bevels and etch were good.A device history record review was completed for provided material number 305195, lot 3271842.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 and a probable root cause could not be determined.
Event or Problem Description
No additional information received materials#: 305195 batch#: 3271842 it was reported by the customer that coring is occurring when they are inserting in medication vials.Verbatim: rcc received a complaint via phone.Pir attached.Productcomplaint-mds; facility: (b)(6) hospital.Address: (b)(6).Dept: in patient pharmacy.Contact: 1.(b)(6) iv team lead 2.(b)(6) pharmacy infusion manager phone: 1.(b)(6).2.(b)(6).Email: 1.(b)(6).2.(b)(6).Ref:1st 305196 lot: 1st 2363714 ref 305195 lot: 2nd 3271842 issue: coring is occurring when they are inserting in medication vials.Doe: unknown.Pt harm: no.Sample: representative samples available.This case is related to (b)(4) when this gets transitioned into tw please relate the cases.

• Brand Name: NEEDLE 18X1 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: 18712215
• Report Number: 1911916-2024-00102
• Device Sequence Number: 12812271
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 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
• Operator of Device: Health Professional
• Device Catalogue Number: 305195
• Device Lot Number: 3271842
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2024
• Supplement Date Received by Manufacturer: 03/02/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown