MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II Y 20GAX1.16IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383012

Device Problem Leak/Splash (1354)

Patient Problems Skin Inflammation (2443); Blood Loss (2597)

Event Date 12/09/2020

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.(b)(4).

Event Description

It was reported that a intima-ii y 20gax1.16in prn/ec slm leaked during use.The following was reported by the initial reporter: "the patient received surgical treatment for the left oblique inguinal hernia.Preoperative preparation and insertion of indwelling needle.The patient's arm was oozing, oozing, and swollen.".

Event Description

It was reported that a intima-ii y 20gax1.16in prn/ec slm leaked during use.The following was reported by the initial reporter: "the patient received surgical treatment for the left oblique inguinal hernia.Preoperative preparation and insertion of indwelling needle.The patient's arm was oozing, oozing, and swollen.".

Manufacturer Narrative

H.6.Investigation: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.A review of the device history record was performed and no quality issues were found during production.

• Brand Name: INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 11152619
• MDR Text Key: 227113646
• Report Number: 3006948883-2021-00055
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Catalogue Number: 383012
• Device Lot Number: 9169510
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1