MAUDE Adverse Event Report: BD CARIBE LTD. 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	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that 3 bd¿ threaded lock cannulas had loose connections with their mating components during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "during using the threaded lock cannula, the hcp noticed that its connection became loose and thus stopped the use.".
Additional Manufacturer Narrative
Investigation summary three physical samples where received for evaluation from material number 303369, lot number unknown.A device history review could not be completed as no batch number was provided.A visual/microscopic evaluation was performed on the returned devices, no physical or molding defects were observed.No damaged was observed to the threads or the micro threads.There were no missing or damage to threads or the micro threads or to the luer lock ears.The returned devices 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.The need for a corrective action cannot be determined in the absence of the root cause.Risk to the end user is established based on occurrence and severity of the defect as related to a specific failure mode in the manufacturing or application process and the effects of that failure.The risk could not be evaluated for the unconfirmed defect in the absence of the root cause.H3 other text : see h.10.
Event or Problem Description
It was reported that 3 bd¿ threaded lock cannulas had loose connections with their mating components during use.The following information was provided by the initial reporter, translated from japanese to english: "during using the threaded lock cannula, 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): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 10946128
• Report Number: 2618282-2020-00102
• Device Sequence Number: 871442
• Product Code: FPA
• 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): 01/26/2021

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: 11/13/2020
• Initial Date Received by Manufacturer: 11/09/2020
• Supplement Date Received by Manufacturer: 01/26/2021
• Initial Report FDA Received Date: 12/04/2020
• Supplement Report FDA Received Date: 01/31/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1