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

Catalog Number 383012

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

It was reported that bd intima-ii y 20gax1.16in prn/ec slm heparin cap was damaged and detached during power injection.The following information was provided by the initial reporter, translated from chinese to english: an inpatient is undergoing coronary angiography in the ct examination room.When the technician pushed the medicine with a high-pressure syringe, the heparin cap on the patient's hand was damaged by the high pressure and fell off.The patient's imaging studies were unsuccessful.

Manufacturer Narrative

H.3.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.Dhr/bhr review(lot#3108455): 1)this batch of products were assembled at intima ii auto line 4 in june 2023, and packaged at cfs package line in june 2023.Work order quantity was 165,000 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 returned.3.Take the retained sample of the complaint batch for relevant functional testing: 1)45psi leakage test is performed, no leakage is found, and no abnormality is found on the prn.2)prn remove torque test is carried out, and the test result is within the product specifications.Please see attachment for the test reports.4.Sku#383012 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.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 the product is not suitable for high pressure injection, the root cause of the prn damage and falling off may be related to the incorrect use of the product.

• Brand Name: BD INTIMA-II Y 20GAX1.16IN PRN/EC SLM
• 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: 18870797
• MDR Text Key: 337307352
• Report Number: 3002601200-2024-00076
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830121
• UDI-Public: (01)00382903830121
• 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: 04/08/2024

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: 383012
• Device Lot Number: 3108455
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1