MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383064

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that tubing expanded with a bd intima-ii¿ 22gax1.00in prn slm npvc.The following information was provided by the initial reporter, translated from (b)(6) to english: it was found tube is bulging and nearly bursting, which causes the alarm of the instrument and the termination of enhanced scanning.Represents a supplementary drip rate of 3.0, < 300 psi.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 9023802.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.Additionally, our engineers were able to evaluate the expanded tubing in the device submitted.Based on their evaluation and the description of the event, they were able to determine that the most likely root cause for this event is the forcing of fluid through the device during injection.The bd intima-ii is an infusion only device and is not rated for high pressure injections.

Event Description

It was reported that tubing expanded with a bd intima-ii¿ 22gax1.00in prn slm npvc.The following information was provided by the initial reporter, translated from japanese to english: it was found tube is bulging and nearly bursting, which causes the alarm of the instrument and the termination of enhanced scanning.Represents a supplementary drip rate of 3.0, < 300 psi.

• Brand Name: BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 8658552
• MDR Text Key: 149218089
• Report Number: 3006948883-2019-00422
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/08/2022
• Device Catalogue Number: 383064
• Device Lot Number: 9023802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2019
• Date Manufacturer Received: 05/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other