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	05/01/2020
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).
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 were unable to connect the catheter adapter/hub with the mating component.The following information was provided by the initial reporter: material no: 386808, batch no: unknown.Event description: difficult to find out if we are in vein.Can¿t screw on hep lok.Blood hemolyzing.
Additional Manufacturer Narrative
H.6.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.
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 were unable to connect the catheter adapter/hub with the mating component.The following information was provided by the initial reporter: material no: 386808; batch no: unknown.Event description: difficult to find out if we are in vein.Can¿t screw on hep lok.Blood hemolyzing.

• Brand Name: SEE H10
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10107525
• Report Number: 8041187-2020-00306
• Device Sequence Number: 11340236
• 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,health professional,o
• 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