MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 20GA 1IN; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 8324804.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.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.
Event or Problem Description
It was reported that needle 20ga 1in leaked.The following information was provided by the initial reporter: "it was reported that when the nurse pulled the plunger back on the 3ml syringe the medication spilled out surrounding the needle/syringe connection point.Per attached follow up response: for 1835952.Incident date? (b)(6) 2020 and (b)(6) 2020.What medication was being drawn up? on (b)(6)- pevnar23 and on (b)(6)- prevnar13.Is product available to return for investigation? this specific product was thrown away but have unused products that can be sent.Event description states: there had been a few instances where one of my clinics have had issues with a couple bd products when they were performing medication administration.In both instances medication sprayed out of the needle/syringe connection point.The products that were used, product # and lot # are below: bd 3ml syringe with luer-lok tip product # 9870248 lot # 0122550, bd precision glide needle 20g x 1¿ product # 9872550 lot # 8324804.Please see the 3 forms for more information.Any information regarding whether this is a product issue or user error would be appreciated.Event details states: in separate instances, my nursing team has had issues with the bd 3ml syringe when they were drawing up or administering medications.The first instance came about when nursing staff tightened a bd precisionglide 20g x 1" needle onto a bd 3ml syringe to draw up medication to administer to a patient.When the nurse pulled the plunger back on the 3ml syringe the medication spilled out surrounding the needle/syringe connection point.".

• Brand Name: NEEDLE 20GA 1IN
• 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: 10687999
• Report Number: 1911916-2020-00960
• Device Sequence Number: 11560447
• Product Code: FMI
• UDI-Device Identifier: 30382903051756
• UDI-Public: 30382903051756
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 305175
• Device Catalogue Number: 305175
• Device Lot Number: 8324804
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2020
• Initial Report FDA Received Date: 10/15/2020
• 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