MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383078

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2021

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 when using the bd intima-ii¿ closed iv catheter system the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "when the pediatric nurse visited the ward, he found the retention needle had a broken tube and needed to do a ct to check of the broken tube position.On 2021-10-26 received update from sales representative, event description updated as follows: the hospital confirmed that a broken tube was found in the digestive tract and described the child as having been excreted out of the body.

Event Description

It was reported when using the bd intima-ii¿ closed iv catheter system the catheter broke/separated from the hub.The following information was provided by the initial reporter.The customer stated: "when the pediatric nurse visited the ward, he found the retention needle had a broken tube and needed to do a ct to check of the broken tube position.2021-10-26 received update from sales representative, event description updated as follows: the hospital confirmed that a broken tube was found in the digestive tract and described the child as having been excreted out of the body.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10/26/2021 h.6.Investigation: a device history review was conducted for lot number 1111431.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 a sample was provided to our facility to aid in our investigation.Our team of engineers have reviewed the device and noted that the tubing exhibited a whitening of the catheter tubing near the break.The issue has been confirmed.Unfortunately the returned device could not be subject to functional testing due to the damage sustained; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Based on the whitening of the tubing our engineers believe that the most likely root cause for this event is related to the application of force during the period of time that the tubing remained in the patient or during the attempt to remove the tubing from the puncture site.See h.10.

• Brand Name: BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12839071
• MDR Text Key: 285228063
• Report Number: 3014704491-2021-00280
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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: 05/16/2024
• Device Catalogue Number: 383078
• Device Lot Number: 1111431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/18/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other