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

Catalog Number	305195
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 305195.Batch#: 4031647, 4060185.It was reported by customer that black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647 exp 5-31-29.Unable to use product.We did not trust the sterility of this item.Product#: 305195.Verbatim: rcc received a complaint via community.Pir attached.Black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647 exp 5-31-29.Unable to use product.We did not trust the sterility of this item.Product#: 305195.
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.
Additional Manufacturer Narrative
Following the submission of the initial mdr, it was noted that a second batch was reported.Batch: 4031647; batch creation date: 2024-01-31; batch expiration date: 2029-05-31.
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there is black contaminant inside the cover of the needle.To aid in the investigation, two samples in sealed packaging blisters from lot 4031647 were received for evaluation by our quality team.A visual inspection was performed.One sample has no defects or imperfections, the other sample has a particulate of dust about 1/8" in size inside the packaging blister.No other defects or imperfections were observed.This defect could occur if, after an equipment repair or scheduled maintenance, cleaning was not properly done.A device history record review was completed for provided material number 305195, lots 4031647 and 4060185.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 sample will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.
Event or Problem Description
Material #: 305195 batch#: 4031647, 4060185.It was reported by customer that black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647 exp 5-31-29.Unable to use product.We did not trust the sterility of this item.Product#: 305195.Verbatim: rcc received a complaint via community.Black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647 exp 5-31-29.Unable to use product.We did not trust the sterility of this item.Product#: 305195.
Additional Manufacturer Narrative
(b)(4).Follow up: it was reported there is black contaminant inside the cover of the needle.A device history record review was completed by our quality engineer team for provided material number 305195 and lot numbers 4031647 and 4060185.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received.Material #: 305195; batch#: 4031647, 4060185.It was reported by customer that black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647, exp 5-31-29.Unable to use product.We did not trust the sterility of this item.Product#: 305195.Rcc received a complaint via community.Black contaminant inside the cover of the needle.4 different needles were found to be contaminated.One lot is listed above, the other is 4031647 exp 5-31-29 unable to use product.We did not trust the sterility of this item.Product#: 305195.

• 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: 20005847
• Report Number: 1911916-2024-00612
• Device Sequence Number: 12527915
• Product Code: FMI
• UDI-Device Identifier: 30382903051954
• UDI-Public: (01)30382903051954(11)240229(17)290331(10)4060185
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,Followup
• Report Date (Section B): 09/19/2024

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: 4060185
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: Not provided; 09/04/2024; 09/19/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 08/22/2024; 09/05/2024; 09/19/2024
• 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