MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II 22GAX1.00IN PRN SLM NPVC; INTERVASCULAR CATHETER

Catalog Number 383064

Device Problem Infusion or Flow Problem (2964)

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

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 3 intima-ii 22gax1.00in prn slm npvc experienced tubing expansion/ballooning during use.The following information was provided by the initial reporter: it was found tube is bulging and nearly bursting, which causes the alarm of the instrument and the termination of enhanced scanning.Batch# unknown.

Manufacturer Narrative

Investigation summary: a dhr was not performed as a lot number could not be submitted for this complaint, and could not be determined from the photographs provided.One sample was returned for evaluation.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 3 intima-ii 22gax1.00in prn slm npvc experienced tubing expansion/ballooning during use.The following information was provided by the initial reporter: it was found tube is bulging and nearly bursting, which causes the alarm of the instrument and the termination of enhanced scanning.Batch# unknown.

• Brand Name: INTIMA-II 22GAX1.00IN 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: 8883551
• MDR Text Key: 156607145
• Report Number: 3006948883-2019-00643
• 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: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383064
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other