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

Model Number	305175
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the needle 20ga 1in experienced leakage at the connection site during use.The following information was provided by the initial reporter: complaint 2 of 5 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.Bd precision glide needle 20g x 1¿ product # 9872550 lot # 8324804.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.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 10/5/2020.H.6.Investigation: a device history record review was completed for provided material number 305175 and lot number 8324804.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, four physical sample were received for evaluation by our quality team.The samples came in sealed packaging blisters.Each was visually inspected with at 10x magnifier lens and no damage or defects were observed.Each sample was then connected to a syringe with saline solution and no leakage was found.Based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.
Event or Problem Description
It was reported that the needle 20ga 1in experienced leakage at the connection site during use.The following information was provided by the initial reporter: complaint 2 of 5 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.Bd precision glide needle 20g x 1¿ product # 9872550, lot # 8324804.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: NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10659134
• Report Number: 1911916-2020-00946
• Device Sequence Number: 17120451
• 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,Followup
• Report Date (Section B): 10/14/2020

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: 01/31/2024
• Device Model Number: 305175
• Device Catalogue Number: 305175
• Device Lot Number: 8324804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 10/14/2020
• 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