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

Catalog Number	302890
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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.
Event or Problem Description
Material#: 302890; lot#: unknown.It was reported by the customer that being clogged by the end user additional information: the lot is 3052475.There have been no reported adverse events.
Event or Problem Description
No additional information received.Material#: 302890, lot#:3052475.It was reported by the customer that being clogged by the end user.Verbatim: rcc received a complaint via email.Email(s) attached over the last few months we have had several complaints regarding pn 302890 (specifically from po (b)(4)) being clogged by the end user.We would appreciate if someone could look into this issue.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported the needle is clogged.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, four photos were provided for evaluation by our quality team.The photos show the inside of a needle hub looking from the bottom up.No defects or imperfections were observed.A device history record review was completed for provided material number 302890, lot 3052475.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 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.
Event or Problem Description
No additional information received material#: 302890, lot#:3052475.It was reported by the customer that being clogged by the end user: rcc received a complaint via email.Email(s) over the last few months: we have had several complaints regarding pn 302890 (specifically from po (b)(4) being clogged by the end user.We would appreciate if someone could look into this issue.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported the needle is clogged.To aid in the investigation, three samples with no packaging blisters and four photos were provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution; each needle expelled the solution with a normal flow.The photos show the inside of a needle hub looking from the bottom up.No defects or imperfections were observed.A device history record review was completed for provided material number 302890, lot 3052475.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 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: 18884751
• Report Number: 1911916-2024-00174
• Device Sequence Number: 7605438
• 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): 05/02/2024

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: 302890
• Device Lot Number: 3052475
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 03/13/2024; 05/02/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 03/13/2024; 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown