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

Catalog Number 383019

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 07/01/2023

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 bd intima-ii y 22gax1.00in prn/ec slm leaked the following information was provided by the initial reporter; on (b)(6) 2023, the nurse to the patient to establish intravenous access, the use of intravenous indwelling needle, placed the needle and the infusion device connected to the infusion about 5 minutes after the discovery of closed intravenous indwelling needle handle and the infusion device connected to a small amount of seepage.After investigation, it was found that the connector of the needle was loose and the infusion set was not tightly fastened, so the needle was immediately replaced and re-punctured, and the patient was pacified and explained well, and the patient expressed her understanding, and the patient was not harmed.

Event Description

No additional information provided.

Manufacturer Narrative

1.Dhr/bhr review (lot#0322490): 1) this batch of products were assembled at intima ii auto line 3 in december 2020, and packaged at r240 package line in december 2020.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.2.No actual samples and pictures have been received, and the defect status cannot be confirmed.3.The retained sample of the complained batch is taken for 45psi leakage test, prn removal torque test and end cap removal torque test.Test results: no leakage is found, the prn removal torque and the end cap removal torque all meet the product specifications.Please see attachment for the test reports.4.In the assembly process of the prn and the end cap, there are torque and assembly stroke monitoring to ensure that their luer can be assembled into the pp connector to a certain depth and their threads have a good fastening effect.If the prn and the end cap are not in place, the equipment will alarm and remove the product.However, although they are fastened to the product during assembly, they may come loose if they are subjected to vibrate during transportation.Therefore, the ifu of the product indicates that the prn and the end cap 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 and retained sample.No similar complaints have been received from other hospitals regarding this batch of products.As no defective sample returned, and the usage of the indwelling needle is unknown, the root cause of the complaint defects cannot be determined.H3 other text : see narrative.

• Brand Name: BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM
• 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: 18219985
• MDR Text Key: 329353132
• Report Number: 3006948883-2023-00112
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830190
• UDI-Public: (01)00382903830190
• 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: 12/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/03/2023
• Device Catalogue Number: 383019
• Device Lot Number: 0322490
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1