MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU INTIMA-II 18GAX1.16IN PRN SLM NPVC; INTRAVASCULAR CATHETER

Catalog Number 383050

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported that intima-ii 18gax1.16in prn slm npvc leaked blood.The following information was provided by the initial reporter, translated from chinese to english: after inserting an indwelling needle into a patient, the nurse manager discovered a blood leak from the isolation plug when withdrawing the needle cartridge, and the blood came into contact with the nurse as well as the patient's hands.

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.

Manufacturer Narrative

1.The customer returned 2 photos, no defective sample.The photos show that there are blood drops at the end of the septum and near the insertion site of the patient, which are not continuous bleeding.2.Dhr/bhr review(lot#3249842): 1)this batch of products were assembled at intima ii auto line 4 in september 2023, and packaged at cfs package line in september 2023.Work order quantity was 15,000 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.The retained samples of this batch are taken for 45psi leakage test.The samples pass the test, and no leakage is found at the end of the septum.Please see the attached test report.4.Possible causes of bleeding at the end of the septum: 1)damage to the septum by the raw material or assembly can result in continuous bleeding at the end of the septum.2)after the needle is punctured into the blood vessel, there is blood at the notch of the needle.In the process of needle removal, although the perforation of the septum is closed, the blood drops in the notch will be brought out with the notch.If there is a lot of inertia in the needle removal process, blood drops will be thrown out.3)if the patient's arm is tied tight during the puncture, it will cause great pressure in the blood vessel, and blood will come out with the needle when the needle is pulled out, but the subsequent blood leakage will not be sustained.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 samples, and no similar complaints have been received from other hospitals about this batch of products.The returned photos show that there are blood drops at the end of the septum and near the insertion site of the patient, which are not continuous bleeding.As we have not received the defective samples, we cannot confirm the root cause of this defect.The plant will continue to monitor this issue.H3 other text : see narrative.

Event Description

No additional information provided.

• Brand Name: INTIMA-II 18GAX1.16IN PRN SLM NPVC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• 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: 18536348
• MDR Text Key: 333251399
• Report Number: 3014704491-2024-00009
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830503
• UDI-Public: (01)00382903830503
• 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: Foreign,Company Representative
• 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: 383050
• Device Lot Number: 3249842
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/18/2024
• Supplement Dates Manufacturer Received: 05/15/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1