MAUDE Adverse Event Report: BD SUZHOU (MDS) BD INTIMA-II Y18GAX1.16IN PRN/EC SLM; INTRAVASCULAR CATHETER

Catalog Number 383005

Device Problem Break (1069)

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

Event Date 02/03/2024

Event Type  malfunction  

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

It was reported that the bd intima-ii y18gax1.16in prn/ec slm catheter broke.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024 at 08:50 the patient broke and bled at the thin thread of an iv indwelling needle during an upper abdominal enhancement, rendering it unusable.

Manufacturer Narrative

1.Description of complaint: "during an upper abdominal enhancement", does it mean that the complained sample was used for upper abdominal enhanced ct examination? 2.Dhr/bhr review (lot#: 3188124).1) this batch of products were assembled at intima ii auto line 4 in july 2023, and packaged at cfs 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.3.No defective samples and photos have been received for the complaint.4.Functional test (45psi leakage test) is conducted on the retained sample of the complained batch.The leakage test is passed, and no abnormality is found at the extension tubing.Please refer to the attached test report.5.Sku#: 383005 is an intima ii product (pvc extension tubing, y connection site).The intended use for the bd intima ii product is the intravascular administration of fluids.This product has never been declared to be used for high-pressure injection.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 about this batch of products.Since no defective sample is received for analysis and confirmation, and the usage of the sample is unknown, the root cause of the fracture of the extension tubing cannot be determined.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II Y18GAX1.16IN 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: 18852519
• MDR Text Key: 337090997
• Report Number: 3002601200-2024-00070
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830053
• UDI-Public: (01)00382903830053
• 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: 03/18/2024

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: 383005
• Device Lot Number: 3188124
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1