MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10; INTERVASCULAR CATHETER

Model Number	386808
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device brand name: bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in.Device expiration date: unknown.(b)(6).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).Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate (b)(4) has been listed and the (b)(4) number has been used for the manufacture report number.
Event or Problem Description
It was reported that an unspecified number of bd cathena safety iv catheters with wings bd multiguard technology 18 ga 1.25 in experienced an inability for the catheter adapter/hub to connect with the mating component during use.The following information was provided by the initial reporter: material no: 386808, batch no: unknown.Event description: difficult to thread++ very difficult to attach saline lock.Difficult to anchor while withdrawing needle.Difficult to see/slow flash.
Additional Manufacturer Narrative
H6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated, as the lot number is unknown.Though an investigation by the manufacturing plant could not be done, sales and marketing did reach out to the customer.During the discussion, it was concluded that there was a lack of understanding of the new product due to lack of training provided.This is a result of covid-19 as they were not allowed to enter the hospital.H3 other text : see h10.
Event or Problem Description
It was reported that an unspecified number of bd cathena safety iv catheters with wings bd multiguard technology 18 ga 1.25 in experienced an inability for the catheter adapter/hub to connect with the mating component during use.The following information was provided by the initial reporter: material no: 386808 ,batch no: unknown.Event description: difficult to thread: very difficult to attach saline lock; difficult to anchor while withdrawing needle; difficult to see/slow flash.

• Brand Name: SEE H10
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10111495
• Report Number: 8041187-2020-00308
• Device Sequence Number: 2561626
• Product Code: FOZ
• UDI-Device Identifier: 00382903868087
• UDI-Public: 00382903868087
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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 Model Number: 386808
• Device Catalogue Number: 386808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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