MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 24GAX0.75IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383033

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/09/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: in response to the event reported by your facility a device history review was conducted for lot number 0322636.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.A sample could not be obtained for evaluation and testing; 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.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

Event Description

It was reported that intima-ii y 24gax0.75in prn/ec slm had a loose tubing clamp.The following information was provided by the initial reporter: "the nurse of the hospital was ready to place a closed vein indwelling needle for the patient.A closed precision indwelling needle was taken out of the box and the package was checked to be complete without damage.After unpacking, the parts were checked and the sealing clamp was found to be a little loose".

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12242745
• MDR Text Key: 264054060
• Report Number: 3006948883-2021-00835
• 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: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/14/2023
• Device Catalogue Number: 383033
• Device Lot Number: 0322636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2021
• Initial Date FDA Received: 07/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• 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