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	03/11/2024
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#: 302890 , lot#: 3198062.It was reported by the customer that they inspected to determine if this issue was across multiple lots.We have found a similar material in the fluid path of the cannula.A total of 3 out of 330 cannulas were found with this issue during inspection, we are not sure the two instances are related but wanted to share this for your information during your investigation.Verbatim: rcc received a complaint via email.Email(s) attached due to the issue with the 30g cannulas a more recent lot (3198062) was inspected to determine if this issue was across multiple lots.We have found a similar material in the fluid path of the cannula.A total of 3 out of 330 cannulas were found with this issue during inspection, we are not sure the two instances are related but wanted to share this for your information during your investigation.
Additional Manufacturer Narrative
(b)(4) follow up.It was reported there was material in the fluid path of the cannula.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a bottom view of the needle hub.There is a white spot shown in the photo that could be related to the lighting.No other information could be obtained from the photos.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.
Event or Problem Description
Additional information received storage conditions are in a designated raw material storage room at ambient conditions.Material#: 30289; lot#: 3198062.It was reported by the customer that they inspected to determine if this issue was across multiple lots.We have found a similar material in the fluid path of the cannula.A total of 3 out of 330 cannulas were found with this issue during inspection, we are not sure the two instances are related but wanted to share this for your information during your investigation.Verbatim: rcc received a complaint via email.Email(s) attached due to the issue with the 30g cannulas a more recent lot (3198062) was inspected to determine if this issue was across multiple lots.We have found a similar material in the fluid path of the cannula.A total of 3 out of 330 cannulas were found with this issue during inspection, we are not sure the two instances are related but wanted to share this for your information during your investigation.

• 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: 19050565
• Report Number: 1911916-2024-00240
• Device Sequence Number: 7270706
• 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
• 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: 03/11/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 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