MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 16X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305197
Medical Device Problem Codes	Contamination (1120); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
No additional information received.Material# 305197, batch# 3320201.It was reported by customer that brown colored discrepancy within the sterile wrapping.It appears that a brown liquid dripped into the safety cap.Verbatim: rcc received a complaint via email.Email(s) attached.S: a pharmacy technician at bridgeport hospital identified a potentially adulterated medication product in the iv room at approximately 1600 on (b)(6) 2024.B: the bd precisionglide 16g x 1 inch needle with lot # 3320201 & exp: 1/31/2029 was identified with a brown colored discrepancy within the sterile wrapping.It appears that a brown liquid dripped into the safety cap.Product#: 305197, lot#: 3320201.
Additional Manufacturer Narrative
Pr 10098438 follow up for device evaluation.It was reported a brown liquid dripped into the safety cap.To aid in the investigation, four samples in sealed packaging blisters and two photos were provided for evaluation by our quality team.A visual inspection was performed.Three of the samples had no defects or imperfections and one sample had equipment lubricant on the plastic shield.The two photos provided show the samples received.This defect could occur during the molding process if equipment lubricant came in contact with the sample.A device history record review was completed for provided material number 305197, lot 3320201.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
Material# 305197 batch# 3320201 it was reported by customer that brown colored discrepancy within the sterile wrapping.It appears that a brown liquid dripped into the safety cap.Verbatim rcc received a complaint via email.Email(s) attached.S: a pharmacy technician at bridgeport hospital identified a potentially adulterated medication product in the iv room at approximately 1600 on (b)(6) 2024.B: the bd precisionglide 16g x 1 inch needle with lot # 3320201 & exp: 1/31/2029 was identified with a brown colored discrepancy within the sterile wrapping.It appears that a brown liquid dripped into the safety cap.Product#: 305197 lot#: 3320201.
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.H3 other text : see h10 manufacture narrative.

• Brand Name: NEEDLE 16X1 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: 19258330
• Report Number: 1911916-2024-00332
• Device Sequence Number: 17758224
• Product Code: FMI
• UDI-Device Identifier: 30382903051978
• UDI-Public: (01)30382903051978
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: 305197
• Device Lot Number: 3320201
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/07/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown