MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. INTIMA-II Y 22GAX1.00IN PRN/EC SLM; INTERVASCULAR CATHETER

Catalog Number 383019

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/08/2019

Event Type  malfunction  

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 intima-ii y 22gax1.00in prn/ec slm experienced a catheter adapter/connector/hub that would not connect to mating component prior to use.The following information was provided by the initial reporter: on (b)(6) 2019, the nurse prepared the patient for preoperative preparation, prepared to place the indwelling needle and puncture to establish the venous passage, and disassembled it, and found that the heparin cap could not be tightened.There was a risk of pollution.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number: 8262029.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.Unfortunately a sample could not be obtained for evaluation and testing.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 and encourages you to submit your sample for review.

Event Description

It was reported that the intima-ii y 22gax1.00in prn/ec slm experienced a catheter adapter/connector/hub that would not connect to mating component prior to use.The following information was provided by the initial reporter: on (b)(6) 2019, the nurse prepared the patient for preoperative preparation, prepared to place the indwelling needle and puncture to establish the venous passage, and disassembled it, and found that the heparin cap could not be tightened.There was a risk of pollution.

• Brand Name: INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 9536058
• MDR Text Key: 179943943
• Report Number: 3006948883-2019-01148
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 383019
• Device Lot Number: 8262029
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other