MAUDE Adverse Event Report: BD (SUZHOU) BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383069

Device Problem Leak/Splash (1354)

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

Event Date 03/28/2024

Event Type  malfunction  

Event Description

It was reported that the bd intima-ii y 22gax1.00in prn ec slm npvc cap was loose.The following information was provided by the initial reporter translated from chinese to english: "when a pregnant woman was undergoing intravenous infusion of oxytocin to induce labor, it was found that there was liquid leakage from a y-shaped interface of the indwelling needle.The inspection found that the heparin cap was not tightly sealed.The heparin cap was immediately replaced and no more leakage occurred.".

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

1.Dhr/bhr review(lot#3052799): 1) this batch of products were assembled at intima ii auto line 3 in march 2023, and packaged at cfs package line in march 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.Among them, the prn torques meet the outgoing inspection requirement.3) review the production records with no nonconformance, deviation or rework activities.4) the prn batch used in this batch of products is 3028230, review the raw material inspection records, no abnormalities.2.No defective samples and photos have been received for the complaint.3.The retained sample of this batch is taken for leakage test and prn removal torque test, the leakage test is qualified, there is no leakage at the prn, and the prn removal torque is within the product specifications.Please see attachment for the test reports.4.In the assembly process of prn, there are torque and assembly stroke monitoring to ensure that the luer of prn can be assembled into the pp connector to a certain depth and the thread has a good fastening effect.If the prn is not in place, the equipment alarms and removes the product.However, although prn is fastened to the product during assembly, it may come loose if it is vibrated during transportation.Therefore, it is recommended that the prn should be tightened before use to prevent leakage.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): no abnormality is found on process retained sample, and no similar complaints have been received from other hospitals regarding this batch of products.As no defective sample is received for further testing and confirmation, the root cause of the untight prn cannot be confirmed.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN 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: 19209502
• MDR Text Key: 342006218
• Report Number: 3002601200-2024-00158
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 05/15/2024

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: Health Professional
• Device Catalogue Number: 383069
• Device Lot Number: 3052799
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1