MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16GX1-1/2IN RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305198
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
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
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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
Complaint from (b)(6) hospital.The customer complained that white foreign bodies were found inside the cap of the needle.
Event or Problem Description
No additional information received.Complaint from prince of wales hospital.The customer complained that white foreign bodies were found inside the cap of the needle.
Additional Manufacturer Narrative
(b)(4) follow up: it was reported foreign matter was found inside the cap of the needle.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly with the plastic shield, but no packaging blister.The needle has what appears to be a piece of plastic towards the top part of the needle.No other defects or imperfections were observed.A device history record review was completed for provided material number 305198, lot 2059704.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 is confirmed.But, without the actual physical sample analysis a probable root cause could not be determined.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported foreign matter was found inside the cap of the needle.To aid in the investigation, one sample with no packaging blister and one photo was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.No piece of plastic of any other foreign matter was found in the sample.The photo shows a needle assembly with the plastic shield, but no packaging blister.The needle has what appears to be a piece of plastic towards the top part of the needle.No other defects or imperfections were observed.A device history record review was completed for provided material number 305198, lot 2059704.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 is confirmed.
Event or Problem Description
No additional information received.Complaint from (b)(6) hospital.The customer complained that white foreign bodies were found inside the cap of the needle.

• Brand Name: NEEDLE 16GX1-1/2IN 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: 18930864
• Report Number: 1911916-2024-00195
• Device Sequence Number: 9291725
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2024

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: 305198
• Device Lot Number: 2059704
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 03/28/2024; 04/13/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/01/2024; 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown