MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30GA 7/8IN BSG CLEAR HUB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	302890
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Material#: (b)(4).Batch#: unknown it was reported by the customer that epoxy in fluid path.Verbatim: rcc received a complaint via email.Email(s) attached we are having more issues with pn 302890, specifically epoxy in fluid path.I have already written the complaint department but have not received any response.
Event or Problem Description
Additional information received.Material#: 302890, batch#: 3198062.It was reported by the customer that epoxy in fluid path.Verbatim: rcc received a complaint via email.Email(s) attached we are having more issues with pn 302890, specifically epoxy in fluid path.I have already written the complaint department but have not received any response.Comments on (b)(6) 2024.I will be sending out the samples this week.Comments on (b)(6) 2024.1) batch number is 3198062.2) samples have been sent.3) we have seen this issue since (b)(6) 2023.5) issue did not involve a patient or user.6) no, event has not involved life threatening situation.7) we have had a minimum of 30 instances found, possibly more.
Event or Problem Description
No additional information received.Material#: 302890 batch#: 3198062.It was reported by the customer that epoxy in fluid path.Rcc received a complaint via email.We are having more issues with pn 302890, specifically epoxy in fluid path.I have already written the complaint department but have not received any response.Comments on 11/02/2024.I will be sending out the samples this week.Comments on 12/04/2024.1) batch number is 3198062.2) samples have been sent.3) we have seen this issue since 12/2023.5) issue did not involve a patient or user.6) no, event has not involved life threatening situation.7) we have had a minimum of 30 instances found, possibly more.
Additional Manufacturer Narrative
Pr (b)(4) follow up.It was reported there was epoxy in the fluid path.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, three photos with magnification were provided for evaluation by our quality team.The photos show a needle hub view from the bottom of the hub.There is a white spot in the photo that could be related to the lighting.No other information could be obtained from the photo.A device history record review was completed for provided material number 302890, lot 3198062.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 photo sample analysis the symptom reported by the customer could not be confirmed.Without the actual physical sample analysis, a probable root cause could not be offered.

• Brand Name: NEEDLE 30GA 7/8IN BSG CLEAR HUB
• 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: 19095653
• Report Number: 1911916-2024-00256
• Device Sequence Number: 15270967
• Product Code: FMI
• UDI-Device Identifier: 50382903028905
• UDI-Public: (01)50382903028905
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 05/07/2024

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: 302890
• Device Lot Number: 3198062
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 05/02/2024; 05/07/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/02/2024; 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown