MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER

Catalog Number	386801
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that one bd cathena¿ safety iv catheter has been found experiencing extravasation during use.The following has been provided by the initial reporter: a dr inserted a cathena cannula for an iron infusion.The iron infusion has stained the arm of the patient (which is likely to be permanent) ? due to extravasation.The dr did not receive education on how to use cannula prior to use.
Additional Manufacturer Narrative
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.
Event or Problem Description
It has been reported that one bd cathena¿ safety iv catheter has been found experiencing extravasation during use.The following has been provided by the initial reporter: a dr inserted a cathena cannula for an iron infusion.The iron infusion has stained the arm of the patient (which is likely to be permanent)? due to extravasation.The dr did not receive education on how to use cannula prior to use.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9309198
• Report Number: 8041187-2019-00910
• Device Sequence Number: 14023999
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• 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,Followup
• Report Date (Section B): 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 386801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/22/2019
• 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