MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD THREADED LOCK CANNULA; INTRAVASCULAR ADMINISTRATION SET

Model Number	303369
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 fluids wouldn't drip from the bd¿ threaded lock cannula when it was connected during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "even after connecting to the threaded lock cannula, fluids didn't drip down.".
Additional Manufacturer Narrative
H.6.Investigation: four photos were received and evaluated.One loose and reportedly used and one sealed packaged threaded lock piece, confirmed to be from batch #9340417 (p/n 303369), were observed in the photos.The loose piece was from cavity 18.No damage and no obvious molding defects were observed in this piece based on the returned photos.The units were given to molding to perform an air water leak test, as an interlink connector is not present in the lab to perform testing on both sides of the device.No leakage was observed.Additionally, the molding department performed a visual examination of the devices and confirmed that no physical damage or molding defects were observed.A root cause cannot be confirmed in the absence of a confirmed defect.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
It was reported that fluids wouldn't drip from the bd¿ threaded lock cannula when it was connected during use.The following information was provided by the initial reporter, translated from japanese to english: "even after connecting to the threaded lock cannula, fluids didn't drip down.".

• Brand Name: BD THREADED LOCK CANNULA
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10742620
• Report Number: 1213809-2020-00742
• Device Sequence Number: 11682535
• Product Code: FMI
• UDI-Device Identifier: 30382903033691
• UDI-Public: 30382903033691
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2021

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: 11/30/2024
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 9340417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2020
• Initial Date Received by Manufacturer: 10/01/2020
• Supplement Date Received by Manufacturer: 01/11/2021
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 01/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1