MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE ADMIX NOKOR 18X1-1/2 TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305215
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	10/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 300779.Batch#: unknown.It was reported by the customer that "after using this needle to introduce particulate free water into their vial through the stopper, we observed particulate floating in the vial.That particulate was identified as acrylic polymer.The client has requested i reach out to bd to determine rule out this needle as a potential root cause for this contamination." is there any documentation bd can provide discussing materials of construction, cleaning/sterilization, or material quality testing that would help with this investigation?.
Additional Manufacturer Narrative
(b)(6): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Patient problem code: f27 ¿ no patient involvement.Device problem code: a180104 - device contamination with chemical or other material.
Event or Problem Description
No additional information received.Material#: 305215 batch#: 2363728 it was reported by the customer that "after using this needle to introduce particulate free water into their vial through the stopper, we observed particulate floating in the vial.That particulate was identified as acrylic polymer.The client has requested i reach out to bd to determine rule out this needle as a potential root cause for this contamination." verbatim: rcc received the complaint via email.Email(s) as attached.We utilized these needles in a vial dilution study for one of our client¿s injectable products.After using this needle to introduce particulate free water into their vial through the stopper, we observed particulate floating in the vial.That particulate was identified as acrylic polymer.The client has requested i reach out to bd to determine rule out this needle as a potential root cause for this contamination.Is there any documentation bd can provide discussing materials of construction, cleaning/sterilization, or material quality testing that would help with this investigation? response received on 09-nov-2023.¿ can you please provide the lot number of the affected product? lot 2363728 ¿ is there sample available to return for further evaluation? we can ship samples.Need to know quantity and shipping information.¿ if no, can a photo be provided? ¿ what did the fm look like? (color / size, liquid like or powder like)? see pictures below.Response received on 14-nov-2023.Bd team, see picture of material to confirm part number and lot.I will work to get this material shipped.Mat# 305215 batch# 2363728.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation it was reported, after using the needle, there was a particulate identified as acrylic polymer floating in a vial.To aid in the investigation, one hundred samples in sealed packaging blisters and two photos were provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.One photo provided shows a particulate at 400x magnification labeled 'from the vial.' the second photo shows a packaging shelf box label.No other information could be obtained from the photos.Acrylic polymer is not used in the production of this unit, or in the manufacturing process.A device history record review was completed for provided material number 305215, lot 2363728.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 returned sample analysis the symptom reported by the customer could not be confirmed.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr for additional information received from the customer.Initial mdr submitted with the incorrect material number.
Event or Problem Description
Material#: 305215.Batch#: 2363728.It was reported by the customer that "after using this needle to introduce particulate free water into their vial through the stopper, we observed particulate floating in the vial.That particulate was identified as acrylic polymer.The client has requested i reach out to bd to determine rule out this needle as a potential root cause for this contamination." response received on 09-nov-2023.Can you please provide the lot number of the affected product? lot 2363728 is there sample available to return for further evaluation? we can ship samples.Need to know quantity and shipping information.If no, can a photo be provided? what did the fm look like? (color / size, liquid like or powder like)? see pictures below.Response received on 14-nov-2023.Bd team, see picture of material to confirm part number and lot.I will work to get this material shipped.

• Brand Name: NEEDLE ADMIX NOKOR 18X1-1/2 TW
• 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18100181
• Report Number: 1911916-2023-00833
• Device Sequence Number: 17499836
• Product Code: GAA
• UDI-Device Identifier: 00382903052158
• UDI-Public: (01)00382903052158
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 11/29/2023
• 2 Devices were Involved in the Event: 1 2

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: 305215
• Device Lot Number: 2363728
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2023
• Supplement Date Received by Manufacturer: 10/23/2023; 11/29/2023
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 11/16/2023; 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown