MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 24GAX0.56IN PRN SLM NPVC; INTERVASCULAR CATHETER

Catalog Number 383085

Device Problem Infusion or Flow Problem (2964)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the intima-ii 24gax0.56in prn slm npvc experienced an incomplete flush during use.The following information was provided by the initial reporter: on (b)(6) 2019, the child was admitted to the hospital due to alveobronchiolitis.Today was the fourth day of admission, and today was the second day of indwelling needle indwelled.The nurse rushed the tube and withdrew blood for the child.Blood clots were found in the indwelling needle tube, and the indwelling needle was immediately replaced, causing the second puncturing of the child without causing other injuries, and then reported to the equipment department.

Manufacturer Narrative

Further review of this incident has changed the adverse event type to flow issues and catheter/needle clogged or occluded.These events are not considered reportable, therefore this complaint should be disregarded.

Event Description

It was reported that the intima-ii 24gax0.56in prn slm npvc experienced an incomplete flush during use.The following information was provided by the initial reporter: on (b)(6) 2019, the child was admitted to the hospital due to alveobronchiolitis.Today was the fourth day of admission, and today was the second day of indwelling needle indwelled.The nurse rushed the tube and withdrew blood for the child.Blood clots were found in the indwelling needle tube, and the indwelling needle was immediately replaced, causing the second puncturing of the child without causing other injuries, and then reported to the equipment department.

• Brand Name: INTIMA-II 24GAX0.56IN PRN SLM NPVC
• 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: 9534274
• MDR Text Key: 179943097
• Report Number: 3006948883-2019-01139
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/22/2021
• Device Catalogue Number: 383085
• Device Lot Number: 7356454
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other