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

Model Number	303369
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/09/2020
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 the bd¿ threaded lock cannula had a loose connection with the mating component during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "during using the threaded lock cannula in an endoscopy room, the hcp noticed that its connection became loose and thus stopped the use.".
Additional Manufacturer Narrative
H.6.Investigation: six photos and one loose threaded lock hub were received and evaluated.A visual/microscopic evaluation was performed on the returned device, no physical or molding defects were observed.No damaged was observed to the threads or the micro threads.There were no missing or damaged to the luer lock ears.The returned device did not display any adverse characteristics that would contribute to the defect the customer experienced.It is unknown what kind of connector was used during the reported incident; therefore, it is impossible to verify if a compatible connection device was used during use.The defect connections issues was not confirmed.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 the bd¿ threaded lock cannula had a loose connection with the mating component during use.The following information was provided by the initial reporter, translated from japanese to english: "during using the threaded lock cannula in an endoscopy room, the hcp noticed that its connection became loose and thus stopped the use.".

• 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: 10945999
• Report Number: 1213809-2020-00867
• Device Sequence Number: 3043636
• 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): 01/28/2021

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: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: 9323673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1