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	05/14/2024
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# 305197 batch# 3320201 it was reported by customer that the needles were bent and broken.Verbatim: rcc received a complaint via email.Email(s) attached we have product that is non-conforming, under complaint number (b)(4).Lot 3320201 is defective.Bent and broken needles.We would like to return all items under this lot number for credit.We have product in our jacksonville, fl location: vendor item: 305197 lot #: 3320201 qty: (b)(4).
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needles were bent and broken.To aid in the investigation, thirteen hundred samples in sealed packaging blisters were received for evaluation by our quality team.Two hundred samples were randomly selected for investigation.A visual inspection was performed, and no defects or imperfections were 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.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.Material# 305197, batch# 3320201.It was reported by customer that the needles were bent and broken.Verbatim: rcc received a complaint via email.We have product that is non-conforming, under complaint number 120784.Lot 3320201 is defective.Bent and broken needles.We would like to return all items under this lot number for credit.We have product in our jacksonville, fl location: vendor item: 305197, lot #: 3320201, qty: (b)(4) each.

• 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: 19475823
• Report Number: 1911916-2024-00397
• Device Sequence Number: 17910347
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 07/12/2024

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: Not provided
• Supplement Date Received by Manufacturer: 07/12/2024
• Initial Report FDA Received Date: 06/06/2024
• Supplement Report FDA Received Date: 07/12/2024
• 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