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.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 8079077.Our records show that this is the only instance of a broken catheter 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 reviewed the device submitted to our facility.Their inspection of the broken section of the catheter identified key characteristics that indicate the catheter was physically pulled apart.To confirm the lot's conformance to product parameters, our engineers tested the available retention samples for pull force resistance; the results found all of the retained devices to be with product specification.Based on our findings and your description of the events leading up to the failure, the root cause for this complaint could not be determined at the conclusion of our review.

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 29, 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
• 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
• 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: 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: Health Professional
• Device Expiration Date: 05/05/2021
• Device Catalogue Number: 383078
• Device Lot Number: 8079077
• Date Manufacturer Received: 12/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 MO