MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305195
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	08/01/2024
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
Materials#: 305195, batch#: 4040643.It was reported by the customer that contamination inside the sterile packaging of needle.Verbatim: contamination inside the sterile packaging of needle.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported there is contamination inside the sterile packaging of needle.To aid in the investigation, one sample in a sealed packaging blister and two photos were provided for evaluation by our quality team.A visual inspection was performed, and there is a dark colored particle, 1/16" in size, adhered to the packaging blister bottom web.The two photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if, after equipment maintenance or repair, cleaning was not effective inducing the foreign matter reported.A device history record review was completed for provided material number 305195, lot 4040643.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.The sample will be shown to associates for awareness.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 is confirmed.
Event or Problem Description
No additional information received.Materials#: 305195, batch#: 4040643.It was reported by the customer that contamination inside the sterile packaging of needle.Verbatim: contamination inside the sterile packaging of needle.

• Brand Name: NEEDLE 18X1 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: 19905313
• Report Number: 1911916-2024-00566
• Device Sequence Number: 21049691
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/24/2024

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: 305195
• Device Lot Number: 4040643
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2024
• Supplement Date Received by Manufacturer: 08/24/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown