MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 22GX1.00IN WINGED BC; INTRAVASCULAR CATHETER

Model Number	386813
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown device manufacture date: unknown investigation summary: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A device history record could not be evaluated as the lot number is unknown.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.If samples are received in the future the complaint will be re-opened and re-investigated.Investigation conclusion: complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.Root cause description: the root cause could not be determined.Rationale: the complaint will be monitored and tracked.
Event or Problem Description
It was reported that cathena 22gx1.00in winged bc will not move forward causing the patient's vein to blow and blood to flow.This was discovered during use.The following information was provided by the initial reporter: material no: 386813 batch no: unknown.It was reported that during patients infusion, when introducing the above cathlon into patient¿s vein the plastic cathlon will not move forward causing the vein to blow, blood flow on insertion when removing the needle occurs.

• Brand Name: CATHENA 22GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10382566
• Report Number: 8041187-2020-00472
• Device Sequence Number: 14153886
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2020

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: Health Professional
• Device Model Number: 386813
• Device Catalogue Number: 386813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/07/2020
• 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