MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 20X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305176
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: 13 samples were received.Two came with no packaging blister; the other 11 samples came in sealed packaging blister.Visual inspection was performed.The two samples with no packaging blister were first examined; one has discolored needle the other one not.The other 11 needles in sealed packaging blister were also visually inspected, they do not have discoloration.One photo was provided.It shows two needle assemblies without the plastic shield.One has the needle with normal finishing/ color; the other has discoloration.This characteristic is cannula surface, not foreign matter.It is appearance.This discoloration occurred during the cannula processing; after this phenomenon was created, the needle is washed, clean, inspected.The discoloration will not come off.Additionally, as part of the needle assembly process a layer of silicone is applied to the needle.It would not come off if the surface is discolored even if it is rubbed with something.It is not a common issue, but we know about the phenomenon and where it can happen, as well as its avoidance.Clearly this is an escape.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: it happened during cannula drawing process.Rationale: capa not required at this time.
Event or Problem Description
It was reported that needle 20x1-1/2 rb had discoloration.This occurred on 10 occasions before use.The following information was provided by the initial reporter: material no: 305176 batch no: 9078980.It was reported that 10 needles appear darker in color than the rest of the lot.

• Brand Name: NEEDLE 20X1-1/2 RB
• 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: 10015970
• Report Number: 1911916-2020-00422
• Device Sequence Number: 2502580
• Product Code: FMI
• UDI-Device Identifier: 30382903051763
• UDI-Public: 30382903051763
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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
• Report Date (Section B): 04/23/2020

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: 05/31/2024
• Device Model Number: 305176
• Device Catalogue Number: 305176
• Device Lot Number: 9078980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other