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

Catalog Number 383083

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 10/22/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd intima-ii y 24gax0.75in prn ec slm npvc catheter was defective / damaged.On (b)(6) 2023, when establishing intravenous access for a child, , the nurse found that the tip of the closed iv needle was blunt and resistant when puncturing, and it was not easy to return blood after successful puncture, and the needle was astringent when withdrawing the needle, and the silicone hose at the needle tip cracked.

Manufacturer Narrative

A correction made to the reported event malfunction and imdrf annex a code & term in response to the event reported by your facility a device history review was conducted for lot number: 3108467 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 and encourages you to submit your sample for review.

Event Description

It was reported that bd intima-ii y 24gax0.75in prn ec slm npvc catheter was tip was cracked.The following information was provided by the initial reporter: on (b)(6) 2023, when establishing intravenous access for a child, , the nurse found that the tip of the closed iv needle was blunt and resistant when puncturing, and it was not easy to return blood after successful puncture, and the needle was astringent when withdrawing the needle, and the silicone hose at the needle tip cracked.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review(lot#3108467): 1)this batch of products were assembled at intima ii auto line 4 in may 2023, and packaged at cfs package line in may 2023.Work order quantity was (b)(4) ea.2)review the in-process test reports and outgoing test reports, and all test results meet the product specifications.3)review the production records with no nonconformance, deviation or rework activities.2.No actual samples and photos have been received, and the defect status cannot be confirmed.3.The retained sample of the complaint batch is taken for lie distance test, penetration force test, blood return test and needle removal force test test.The test results are all within the product specifications.4.Possible cause: 1)needle bluntness and catheter split: it is related to the product's lie distance, needle tip force, catheter tip force, catheter drag force, as well as the patient's skin, vascular conditions and puncture method.It is recommended to insert the needle at 15°~30° with the bevel of the needle tip upwards, then lower the angle to 5°~10° to send the needle and catheter, do not withdraw the needle prematurely, and never reinsert the needle into the catheter.2)blood does not return easily after successful puncture: product blockage, the patient's skin, vascular conditions, and puncture method can affect blood return, and product blockage can be detected during the exhaust process before puncture.3)the needle is astringent when withdrawing the needle: there may be residual silicone between the needle and the septum.The silicone condensate will lead the needle and the septum disengagement difficulty.The operation procedure of the ifu indicates that the needle needs to be loosened before puncture.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process and retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.Since no defective sample is received, further analysis cannot be conducted, and the root cause of the complained defects cannot be determined, and the plant will continue to track and trend for this issue.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer (Section G): BD SUZHOU (MDS); #5 baiyu road; suzhou industrial park; jiangsu 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18740603
• MDR Text Key: 335949971
• Report Number: 3002601200-2024-00042
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 383083
• Device Lot Number: 3108467
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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