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

Catalog Number 383033

Device Problem Break (1069)

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 24gax0.75in prn/ec slm broke.The following information was provided by the initial reporter, translated from chinese to english: "a break in the indwelling needle hose was noted while administering iv fluids to a patient using a closed iv needle.".

Manufacturer Narrative

E1: address information was not provided, therefore, xx was used as a place holder.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

A break in the indwelling needle hose was noted while administering iv fluids to a patient using a closed iv needle.

Manufacturer Narrative

1.Dhr/bhr review (lot#: 3108395): 1) this batch of products were assembled at intima ii auto line 2 in june 2023, and packaged at r240 package line in june 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.4) review incoming inspection records of catheter, no abnormalities.(material number: b5171aaal, batch number: 2304672, 3083131).2.No defective samples and photos have been received for the complaint.3.The retained sample of this is taken for 45psi leakage test and catheter pull force test.No leakage is found at the catheter, and the catheter pull force is within the product specifications.4.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.As the specific site and state of the break of the catheter cannot be confirmed, and the usage of the complained sample is unknown, the root cause of the catheter break cannot be determined.

• Brand Name: BD INTIMA-II Y 24GAX0.75IN 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: 18681311
• MDR Text Key: 335324550
• Report Number: 3002601200-2024-00028
• 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: 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: 03/19/2024

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: 383033
• Device Lot Number: 3108395
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/25/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/28/2024
• 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