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

Catalog Number 383012

Device Problems Break (1069); Burst Container or Vessel (1074); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 03/27/2019

Event Type  Injury  

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 a high-pressure ct injection of "iohexo" administered through the intima-ii y 20gax1.16in prn/ec slm leaked at the broken prn during use, leading to "iohexol splash" and ct scan failure, where the patient had to be retested again after two days.The following information was provided by the initial reporter, translated from chinese to english: "it was found high-pressure ct injection of iohexo leakage at prn, prn broken, leaking to iohexol splash and ct scan failure, do again after 2 days.(b)(6) 2019 rep confirmed with staff, operation during injection led prn exploded.Hospital has changed operation mode".

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 8262041.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Unfortunately a sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that a high-pressure ct injection of "iohexol" administered through the intima-ii y 20gax1.16in prn/ec slm leaked at the broken prn during use, leading to "iohexol splash" and ct scan failure, where the patient had to be retested again after two days.The following information was provided by the initial reporter, translated from chinese to english: "it was found high-pressure ct injection of iohexol leakage at prn, prn broken, leaking to iohexol splash and ct scan failure, do again after 2 days.(b)(6) 2019 rep confirmed with staff, operation during injection led prn exploded.Hospital has changed operation mode.".

• 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: 8518749
• MDR Text Key: 142084505
• Report Number: 3006948883-2019-00274
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/10/2019

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
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383012
• Device Lot Number: 8262041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 05/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention