MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 18X1-1/2 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305185
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used.(b)(4).Investigation summary: a device history record review was performed for provided lot number 164131.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, 182 physical samples were received for evaluation by our quality team.180 samples came in sealed packaging blisters and 2 came in opened packaging blister.The samples received were inspected with a 10x magnifier lens, and one of the samples that came in an opened packaging blister has string of plastic at the outer edge of the needle hub base.It is not loose and measures s 1/64" long.In addition.4 samples were provided and they show the samples received.The cause for this defect could not be determined.Further action has not been determined necessary at this time.Our quality team will continue to monitor the manufacturing process for this defect and other emerging trends.Investigation conclusion: based on the investigation and with the sample analysis the symptom reported by the customer could not be confirmed.We will continue monitoring the complaint trend for this product and symptom.One sample out of the 182 samples received has a plastic flash that it is acceptable.The specification is up to 0.015" acceptable.
Event or Problem Description
It was reported that 2 needles 18x1-1/2 rb tw experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 305185, batch no: 0164132.Customer reporting precision glide needles with a piece of plastic sticking out of them.They also found a piece of material in a compound sterile product and they think it may be a broken off piece of plastic from our needle.
Additional Manufacturer Narrative
H.6.Investigation: a device history record review was completed for provided material number 305185 and lot number 0164131.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, one hundred eighty two samples and four photos were received for evaluation by our quality team.Of the physical samples received, one hundred eighty came in sealed packaging blisters and two came in open packaging blisters.The samples were inspected with a 10x magnifier lens.One of the samples in an opened packaging blister has plastic flash at the outer edge of the needle hub base.It is not loose, 1/64" long and is within specification.The four photos provided show the sample received.Based on the investigation results, the samples received did not show the symptom reported by the customer.H3 other text : see h.10.
Event or Problem Description
It was reported that 2 needles 18x1-1/2 rb tw experienced foreign matter contamination.The following information was provided by the initial reporter: material no: 305185 batch no: 0164132.Customer reporting precision glide needles with a piece of plastic sticking out of them.They also found a piece of material in a compound sterile product and they think it may be a broken off piece of plastic from our needle.

• Brand Name: NEEDLE 18X1-1/2 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 11285475
• Report Number: 1911916-2021-00094
• Device Sequence Number: 3482478
• Product Code: FMI
• UDI-Device Identifier: 00382903051854
• UDI-Public: 00382903051854
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: Other
• Device Expiration Date: 08/31/2025
• Device Catalogue Number: 305185
• Device Lot Number: 0164131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1