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

Catalog Number	386801
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that a bd cathena¿ safety iv catheter had leakage.The following was reported, "health care professional inserted an 18g in patient's hand, elderly lady who was cooperative, got instaflash, then removed tourniquet, heard the click of the "safety mechanism" with click, blood then splattered up the arm.
Event or Problem Description
It was reported that a bd cathena¿ safety iv catheter had leakage.The following was reported, "health care professional inserted an 18g in patient's hand, elderly lady who was cooperative, got instaflash, then removed tourniquet, heard the click of the "safety mechanism" with click, blood then splattered up the arm.
Additional Manufacturer Narrative
Investigation summary: 1 representative samples was returned for evaluation.The sample was subjected to visual inspection and blood escape test (bet).The sample passed both visual inspection and blood escape test.No abnormality was observed.The complaint is unconfirmed as no defect was observed on the sample.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.No abnormality was observed during the production of the reported batch.The investigation was not able to confirm the what customer had experienced as the sample pass visual inspection and blood escape test.Hence, root cause is unable to be determined.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8444368
• Report Number: 8041187-2019-00248
• Device Sequence Number: 345321
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 04/26/2019

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: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 386801
• Device Lot Number: 8060125
• Initial Date Received by Manufacturer: 03/05/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/22/2019
• Supplement Report FDA Received Date: 04/26/2019
• 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