MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II; INTERVASCULAR CATHETER

Catalog Number 383405

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that one 18g x 1.16in (1.3 x 30 mm) w/ y intima ii has been found experiencing leakage during use.The following has been provided by the initial reporter: when the nurse used the intravenous indwelling needle to infuse the patient: after the injection and pulling the hard needle, there is blood leakage in the place where the needle is pulled.Need to replace the indwelling needle and need to re-penetrate.There is a possibility of increasing the chance of infection.

Event Description

It has been reported that one 18g x 1.16in (1.3 x 30 mm) w/ y intima ii has been found experiencing leakage during use.The following has been provided by the initial reporter: when the nurse used the intravenous indwelling needle to infuse the patient: after the injection and pulling the hard needle, there is blood leakage in the place where the needle is pulled.Need to replace the indwelling needle and need to re-penetrate.There is a possibility of increasing the chance of infection.

Manufacturer Narrative

This mfr.Report # 3006948883-2019-00775 is void.The complaint has been captured under mfr.Report # 3006948883-2019-00584.

• Brand Name: 18G X 1.16IN (1.3 X 30 MM) W/ Y INTIMA II
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9082882
• MDR Text Key: 178791265
• Report Number: 3006948883-2019-00775
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K143610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 383405
• Device Lot Number: 7047028
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other