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

Catalog Number 383083

Device Problem Break (1069)

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

Event Date 01/04/2024

Event Type  malfunction  

Event Description

It was reported that a break was found on the bd intima-ii y 24gax0.75in prn ec slm npvc.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital due to a fall at home and was diagnosed with an intertrochanteric fracture of the right femur.On (b)(6) 2024, the nurse followed the doctor's instructions and used a closed intravenous indwelling needle to perform intravenous infusion for the patient.After flushing the tube, the indwelling needle and the infusion set were connected and ready for infusion.When it was found that the infusion was not dripping, there was no obvious abnormality at the site of the indwelling needle.Immediately report to the head nurse and pull out the indwelling needle.After pulling out, it was found that the hose was broken.Immediately replaced with a new indwelling needle and re-punctured it.After using it normally, the patient's intravenous indwelling infusion was successfully performed.No obvious harm was caused to the patient.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.E1.Address information was not provided, therefore, xx was used as a place holder.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

No additional information provided.

Manufacturer Narrative

1.In the attachment, we have communicated with the customer and learned that: 1)the catheter was not broken, and it was split.2)the catheter was intact before insertion.After analysis, it was found that the skin was picked when the needle was inserted into the patient's blood vessel, and the needle core was pulled out at an angle, resulting in the catheter being split.3)no catheter is remained in the patient.2.No defective samples and photos have been received for the complaint.3.The catheter of bd indwelling needle has always been provided by bd sandy factory.The characteristics of the catheter are good biocompatibility, excellent bending resistance, and the catheter separate force is much higher than the national standard yy 1282-2016.4.Dhr review and retained sample analysis are not performed as the batch code (20010201) of this complaint is wrong.Conclusion(s): through communication with the customer, we learned that the catheter was intact before insertion, and the split of the catheter may be related to the puncture method, and we have not received defective sample for more testing and analysis, so we cannot confirm that this complaint is related to product quality.

• Brand Name: INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC
• 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: 18567975
• MDR Text Key: 333541914
• Report Number: 3014704491-2024-00033
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830831
• UDI-Public: (01)00382903830831
• 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: 04/11/2024

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: 383083
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/24/2024
• 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