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	01/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305198 batch number#: 3271988 , 3236172.It was reported by consumer that there were also a couple of needles that on the purple attachment had black specks identified upon opening the overwrap from 2 different lots.
Additional Manufacturer Narrative
(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
Additional information received the product was not used for any preparation or on any patient.Material#: 305198, batch number#: 3271988 , 3236172.It was reported by consumer that there were also a couple of needles that on the purple attachment had black specks identified upon opening the overwrap from 2 different lots.Verbatim: there were also a couple of needles that on the purple attachment had black specks identified upon opening the overwrap from 2 different lots.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported there were black specks.To aid in the investigation, eight samples in opened packaging blisters and one photo was provided for evaluation by our quality team.One sample was from lot 3271988 and seven samples were from lot 3236172.A visual inspection was performed with 10x magnification.All the samples have embedded degraded resin in the needle hub.The photo provided shows one of the samples received.No other defects or imperfections were observed.The embedded degraded resin in the component typically occurs at the startup or intermittently during the injection molding process.The degraded resin can break loose and be molded into components.A device history record review was completed for provided material number 305198, lots 3271988 and 3236172.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The samples 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.

• 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: 18650064
• Report Number: 1911916-2024-00058
• Device Sequence Number: 15504134
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 02/28/2024

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: 3236172
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 02/28/2024
• Initial Report FDA Received Date: 02/06/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown