MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383083

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history review was conducted for lot number 9323921.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.Investigation conclusion: observed retained samples under the microscope and didn¿t find the complained defect.From the returned photo, the indwelling needle was rusted.Root cause description: based on our analysis of the provided photograph the most likely root cause for this event is exposure to a humid environment during transportation or storage.A review of the available retention samples were not able to identify any additional instances of rust in this batch of intima-ii.The factory has also received the same defective products in the past, and sent the defective products to the relevant laboratories of (b)(4) for component analysis.The results of component analysis showed that the main component of the defective substance was iron, and the other components included o, cr, ni, c and cl.O and chlorine accounted for 30.7% and 0.8% respectively.According to our understanding of the material of the needle tube, the needle tube is 304ss material, except for the main component iron, the other components are 0cr18ni9.The 304ss stainless steel is the main material used by all manufacturers in the production of needles.Although under normal conditions, the material has good corrosion resistance, but in special circumstances, such as in the presence of corrosive gases such as chlorine (or sodium hypochlorite), the needle tube will not be excluded from similar corrosion.According to the factory's previous experience, the main reason for the corrosion of this indwelling needle tube materials may be that this product was corroded by chlorinated chemicals in the air during transportation or storage.Under this particular condition, some of the needles may be corroded, the factory did not have the external conditions that led to the defect during the indwelling needle production process.This may occur under certain conditions such as air corrosion of chlorinated chemicals during transportation or storage.The factory does not have the conditions to cause the defect.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that 3 bd intima-ii¿ closed iv catheter system needles were rusted.The following information was provided by the initial reporter, translated from chinese to english: "the rust was found in the indwelling needle".

• Brand Name: BD INTIMA-II CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11175503
• MDR Text Key: 227074538
• Report Number: 3006948883-2021-00104
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/19/2022
• Device Catalogue Number: 383083
• Device Lot Number: 9323921
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2019
• 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