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

Catalog Number 383028

Device Problems Fluid/Blood Leak (1250); Device Contamination with Chemical or Other Material (2944); Material Split, Cut or Torn (4008)

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

Event Date 06/13/2021

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 0231288.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.Dhr review: the complaint gauge is 24g,assembly at auto line 2 in oct.2020,packaging at cfs packing machine in oct.2020, lot quantity is 136k.Review the in process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it.Review the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities.Complaint information description: the resistance was high when inserting the needle.After pulling out, the needle core was bent and the catheter burst.No actual sample and picture returned ,the defect status could not be confirmed.Check incoming inspection records of needle core , no abnormality was observed.(material number: 8515555, batch number: 9362419).Check incoming inspection records of catheter , no abnormality was observed.(the catheter for production of this batch is panel material, material number: b5171aaal, batch number: 9248032/9311274).Test the retained sample of the same batch number: 2 retained samples of this lot were taken for penetration force test, the lie distance, the needle tip, catheter tip and catheter drag force met the product specification.At the same time, the catheter was observed under the microscope and no abnormality observed.Conducted the rigidity and toughness tests these 2 retained samples were inspected, the result met the product specification.According to the experience of previous market visits, suggested the customers: the needle core and the catheter into the blood vessel at 15°~30°, withdraw the needle core by 2mm.And then the needle core should be slowly lowered to 5°~10 ° to send the catheter into the blood vessel.No same complaint was received from the complaint lot.Conclusion(s): no abnormal found on process, as no defective sample returned, and the use status of nurses was unknown, the root cause of the customer complaint cannot be identified.No need for capa.

Event Description

It was reported that intima-ii 24gax0.75in prn slm catheter was damaged.The following information was provided by the initial reporter: at 9:25 on june 13, the indwelling needle was found to be blocked, and the catheter was re-inserted.The nurse used a 24g indwelling needle to insert the catheter, but the resistance was high when inserting the needle, and it was found that the tube was twisted and could not be inserted any more, so the catheter was removed immediately.After pulling out, the indwelling needle core was bent and the catheter tube burst.The patient's family did not agree to use the indwelling needle again, refused the infusion, signed as evidence, no adverse consequences occurred.

• Brand Name: INTIMA-II 24GAX0.75IN PRN SLM
• Type of Device: CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• MDR Report Key: 12346078
• MDR Text Key: 267443960
• Report Number: 3006948883-2021-00889
• 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
• Report Date: 08/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/06/2023
• Device Catalogue Number: 383028
• Device Lot Number: 0231288
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• 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