MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	386808
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in safety mechanism was difficult to remove.The following information was provided by the initial reporter: "it was reported that the catheter is difficult to advance without blowing veins, flashback is poor and can't tell if still in vein, difficult to disconnect and patients were complaining of more pain that usual.Event description per attached email states: insertion seems more painful to patients.Difficult to advance."blows" vein.Can't tell by blood flow if cath is still in vein.Difficult to disconnect (need 2 hands).Difficult to attach to saline set.".
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in safety mechanism was difficult to remove.The following information was provided by the initial reporter: "it was reported that the catheter is difficult to advance without blowing veins, flashback is poor and can't tell if still in vein, difficult to disconnect and patients were complaining of more pain that usual.Event description per attached email states: insertion seem smore painful to patients.Difficult to advance."blows" vein.Can't tell by blood flow if cath is still in vein.Difficult to disconnect (need 2 hands).Difficult to attach to saline set.".
Additional Manufacturer Narrative
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.

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10112278
• Report Number: 8041187-2020-00316
• Device Sequence Number: 19473249
• 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