MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y 20GAX1.16IN SS PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383061

Device Problem Material Rupture (1546)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 20gax1.16in ss prn slm npvc leaked.The following information was provided by the initial reporter, translated from chinese to english: 2024.1.25 pm 1.30 or so patients do coronary artery ct imaging (cta) examination in the injection of iopromide injection, closed intravenous indwelling needle 20g, heparin cap burst, blood and drugs out of the body about 10ml, the examination is terminated, contact the nurse to check the indwelling needle and vein, replace the heparin cap.

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 3 photos, no defective sample.The photos show that the sku is 383061, the batch code is 3108451, the gauge is 20g-y lure, the middle of the sleeve stopper of the prn is burst, the large end of the sleeve stopper and the shrink band are assembled in place.2.Dhr/bhr review(lot#3108451): 1)this batch of products were assembled at intima ii auto line 4 in (b)(6) 2023, and packaged at r245 package line in (b)(6) 2023.Work order quantity was (b)(4).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.3.The ifu of the product indicates: 1) the intended use for the bd intima ii plus device is the intravascular administration of fluids, medication, or blood and blood products, and for obtaining of blood samples.2) 20g, 22g, and 24g straight lure product can withstand 300psi pressure.Connectors should be removed before use.4.The retained sample of this batch is taken for 45psi leakage test, no leakage is found, and no abnormality is found on the prn.Please see the attached test report.Conclusion(s): 1) the returned photos show that the middle of the sleeve stopper of the prn is burst.2) judging from the state of other parts of the prn, there is no quality problem in the assembly of the prn.3) the root cause of the sleeve stopper bursting in the middle is that the complained sample was mistakenly used for coronary ct examination.

• Brand Name: BD INTIMA-II Y 20GAX1.16IN SS PRN 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); no. 5 baiyu road; suzhou industrial park; suzhou 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18764171
• MDR Text Key: 336961458
• Report Number: 3002601200-2024-00051
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830619
• UDI-Public: (01)00382903830619
• 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: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2024

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: Other
• Device Catalogue Number: 383061
• Device Lot Number: 3108451
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 03/24/2024
• Supplement Dates FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1