MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER

Catalog Number 383078

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Inflammation (1932); Swelling (2091); Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2018

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 the bd intima-ii¿ closed iv catheter system left a broken cannula after insertion. Customer said "the nurses pulled out the needles at the request of their families around 11 a. M. , (b)(6) 2018. When they pulled out the catheter, they found that they were broken. Immediately report to the nursing department and take emergency measures to confirm the location of the residual catheter in the temporofrontal region by x-ray and three-dimensional color doppler ultrasonography. On the afternoon of (b)(6), after consultation with surgeons, the catheter was sent to the operating room at about 17:30, and the operation ended at about 18:20, with unknown results. When the catheter was pulled out, it was found that it was broken in the middle of the catheter, and there was no abnormality at the puncture point except for slight redness and swelling. ".

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 8257384
• MDR Text Key: 133512633
• Report Number: 3006948883-2018-00431
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/05/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8079077
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/17/2019 Patient Sequence Number: 1