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

Model Number	386808
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
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.
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in had a connecter that could not attach to the mating component.The following information was provided by the initial reporter: "it was reported that the catheter is difficult to advance without blowing veins, hard to attach iv tubing to hub and patients were complaining of more pain that usual.Event description per attached email states: ahs mdip # 3339 / manufacturer code/model: 386808 date of incident (yyyy-mm-dd): (b)(6) 2020.Difficult to advance without blowing patient vein (requires more attempts on patient).Hard to attach iv extension tubing to hub of iv catheter.Patients seem to find them more painful than usual.".
Additional Manufacturer Narrative
H.6.Investigation summary: 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 h.10.
Event or Problem Description
It was reported that bd cathena safety iv catheter with wings bd multiguard technology 18 ga 1.25 in had a connecter that could not attach to the mating component.The following information was provided by the initial reporter: "it was reported that the catheter is difficult to advance without blowing veins, hard to attach iv tubing to hub and patients were complaining of more pain that usual.Event description per attached email states: ahs mdip # 3339 / manufacturer code/model: 386808.Date of incident (yyyy-mm-dd): (b)(6)2020.Difficult to advance without blowing patient vein (requires more attempts on patient).Hard to attach iv extension tubing to hub of iv catheter.Patients seem to find them more painful than usual.".

• 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: 10112229
• Report Number: 8041187-2020-00312
• Device Sequence Number: 16784485
• 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