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

Catalog Number 383033

Device Problems Break (1069); Leak/Splash (1354)

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

Event Date 12/09/2023

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 24gax0.75in prn/ec slm leakage with power injector the following information was provided by the initial reporter: the patient was using a hyperbaric syringe for nuclear magnetic enhancement, and the rubber cap of the closed iv indwelling needle attached to the hyperbaric syringe barrel ruptured while injecting the contrast agent, allowing the patient's blood to escape.

Manufacturer Narrative

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

Manufacturer Narrative

1.Dhr/bhr review(lot#3171623): 1)this batch of products were assembled at intima ii auto line 2 in july 2023, and packaged at r240 package line in july 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 for the complaint.3.Functional test (45psi leakage test) is conducted on the retained sample of the complained batch, no leakage is found, and no abnormality is found at the prn.Please refer to the attached test report.4.The prn can withstand the pressure of 45psi during use.If the pressure is greater than 45psi, the prn may be damaged.5.Sku#383033 is an intima ii product (pvc extension tubing, y connection site), which has not been declared to be used for high-pressure injection.The intended use for the bd intima ii product is the intravascular administration of fluids.6.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 the product is not suitable for high pressure injection, the root cause of the rupture of the sleeve stopper of the prn may be related to the incorrect use of the product.H3 other text : see narrative.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18554103
• MDR Text Key: 333382961
• Report Number: 3014704491-2024-00026
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830336
• UDI-Public: (01)00382903830336
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/14/2024

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: Health Professional
• Device Catalogue Number: 383033
• Device Lot Number: 3171623
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2024
• Initial Date FDA Received: 01/22/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1