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

Catalog Number 383033

Device Problem Component Missing (2306)

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

Event Date 01/18/2024

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 bd intima-ii y 24gax0.75in prn/ec slm was missing a component, the tubing clamp.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted to the hospital with a femur fracture, and on (b)(6) 2024, the charge nurse followed the doctor's orders for intravenous fluid therapy for the patient, and when preparing to perform venipuncture, she found that the closed iv indwelling needle lacked a sealing clip and was unusable, and she immediately replaced it with another indwelling needle without causing harm to the patient.

Event Description

No additional information provided.

Manufacturer Narrative

1.The customer returned 2 photos, no defective sample.The photos show that the sample has no pinch clamp, the sku is 383033, and the batch code is 3080069.2.Dhr/bhr review (lot#: 3080069): 1) this batch of products were assembled at intima ii auto line 2 in may 2023, and packaged at r240 package line in may 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.3.Check the retained samples of this batch, and no sample without pinch clamp is found.Please see attachment for the inspection report.4.In intima ii auto line 2 zone 7, there are visual systems for 100% detection of the assembly of the pinch clamp, the visual systems are stable and effective, every day at 7:00, 19:00 and when changing gauge, standard samples will be used to challenge the visual systems.5.No similar complaints have been received from other hospitals regarding this batch of products.Conclusion(s): the returned photos show that the sample has no pinch clamp.Since no abnormalities are found in the process and retained samples, and from the analysis of the product process, there are visual systems for 100% detection of the assembly of the pinch clamp, the root cause of the pinch clamp missing cannot be determined.This complaint is an isolated case and the plant will continue to track and monitor the defect.

• 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: 18792495
• MDR Text Key: 336412833
• Report Number: 3002601200-2024-00058
• 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: 3080069
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 03/20/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1