MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD THREADED CANNULA INTERLINK; 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	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported while using bd threaded cannula interlink¿ leakage occurred at the connection site.The following information was provided by the initial reporter, translated from (b)(6) to english: after using a threaded lock, the hcp found fluid leakage from the connection.After discovering this issue, the hcp attempted to screw it to the end but felt like it was pushed back.
Event or Problem Description
It was reported while using bd threaded cannula interlink¿ leakage occurred at the connection site.The following information was provided by the initial reporter, translated from japanese to english: after using a threaded lock, the hcp found fluid leakage from the connection.After discovering this issue, the hcp attempted to screw it to the end but felt like it was pushed back.
Additional Manufacturer Narrative
H.6.Investigation: two photos and one loose threaded lock component attached to an extension tubing was received and evaluated.No visual defects were observed on the threaded lock.The sample was forwarded to the manufacturing site for an evaluation and leakage testing.A visual/microscopic evaluation was performed on the returned device, no physical or molding defects were observed.No damage was observed to the threads or the micro threads.There were no missing or small damaged to the luer lock ears.The returned device did not display any adverse characteristics that would contribute to the defect the customer experienced.The device and attached extension tubing were given to molding to perform an air water leak test.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.Probable root cause conclusion: no determined ¿ a root cause cannot be determined in the absence of a unconfirmed defect.Dhr could not be performed due to unknown lot#.

• Brand Name: BD THREADED CANNULA INTERLINK
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 10925427
• Report Number: 1213809-2020-00852
• Device Sequence Number: 14034065
• 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): 02/05/2021

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 Model Number: 303369
• Device Catalogue Number: 303369
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1