MAUDE Adverse Event Report: BD (SUZHOU) INTIMA-II 24GAX0.75IN PRN SLM NPVC; CATHETER

Catalog Number 383078

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/29/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that intima-ii 24gax0.75in prn slm npvc catheter broke.The following information was provided by the initial reporter: at the maternity and child care, pediatrics nurse gave a 4 years old patient inject a closed venous indwelling needle on the morning of (b)(6), after transfusion the patient went home on the afternoon of (b)(6), when the head nurse found the morning ward round, the front part of the catheter tube was missing, the puncture point didn't show any exception, broken tube section was not smooth.The patient's family went home to look for the missing catheter tube, and x-rays and two-dimensional ultrasound were performed on the child.No abnormalities were found.The family found what looked like a catheter tube in their bed at home and asked the company to determine whether it was a broken tube, a fish bone or some other foreign object.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/4/2021.H.6.Investigation: a device history review was conducted for lot number 0357707.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, the sample returned to our facility was reviewed by our quality engineers.During microscopic evaluation, they were able to identify key characteristics along the broken edge of the tubing, which indicate that the damage was sustained through the application of a large tensile force during use.Our engineers were also able to subject the available retention samples to functional testing for tensile force resistance.The results determined that this batch was performing within the limits established by product specifications.H3 other text : see h.10.

Event Description

It was reported that intima-ii 24gax0.75in prn slm npvc catheter broke.The following information was provided by the initial reporter: at the maternity and child care, pediatrics nurse gave a 4 years old patient inject a closed venous indwelling needle on the morning of may 29, after transfusion the patient went home on the afternoon of may 30, when the head nurse found the morning ward round, the front part of the catheter tube was missing, the puncture point didn't show any exception, broken tube section was not smooth.The patient's family went home to look for the missing catheter tube, and x-rays and two-dimensional ultrasound were performed on the child.No abnormalities were found.The family found what looked like a catheter tube in their bed at home and asked the company to determine whether it was a broken tube, a fish bone or some other foreign object.

• Brand Name: INTIMA-II 24GAX0.75IN PRN SLM NPVC
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 12073110
• MDR Text Key: 264975850
• Report Number: 3006948883-2021-00710
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/13/2024
• Device Catalogue Number: 383078
• Device Lot Number: 0357707
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention