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

Catalog Number 383033

Device Problem Separation Problem (4043)

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

Event Date 01/25/2024

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 y 24gax0.75in prn/ec slm had a separated septum on a prn connector.The following information was provided by the initial reporter, translated from chinese to english: "on january 25, 2024, the patient was given a closed intravenous needle, on january 26, the infusion was normal during the day, and the tube was sealed with saline after the infusion, and at 18:00 on january 26, when the infusion was given, it was found that the silicone at the front end of the needle was detached, and the needle was in the state of clamping the tube, with no return of blood, which did not cause any adverse effects to the patient, and the patient was given an immediate replacement of the needle.Manifestations of device failure: the tip of the heparin cap is detached.".

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 1 photo, no defective sample.The photo shows that only the luer part of the adapter of the prn is connected to the pp connector, the front part of the prn is missing, and the sample is indwelled in the patient.2.Dhr/bhr review (lot#: 3135075): 1) this batch of products were assembled at intima ii auto line 4 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) the prn batch used in this batch of products is 3139423, review the raw material inspection records, no abnormalities.3.Check the prns of the retained samples of this batch, no cracks or other damage are found in the adapter.45psi leakage test is carried out on the retained sample, and no leakage is found at the prn.4.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s).No abnormalities are found in the process and retained samples.The returned photo shows the state of the prn after the front part falling off.The root cause of this defect cannot be determined because the plant has never detected this defect, never received a complaint about the defect, and the defective sample has not been returned for further examination and analysis.

• 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: 18717017
• MDR Text Key: 336520812
• Report Number: 3002601200-2024-00041
• 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: 03/20/2024

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: 3135075
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1