MAUDE Adverse Event Report: BD SUZHOU (MDS) BD 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 12/25/2023

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.Additional information was received 02/05/2024 verbatim from follow-up: "there were (b)(4) on (b)(6) and (b)(4) was found after i went to follow the needle for 1 hour on (b)(6).There were also cases operated by the nurse before (b)(6) and the specific time was not provided by the client.".

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

Correction made to the date received by manufacturer.

Manufacturer Narrative

In response to the event reported by your facility a device history review was conducted for lot number 3249842.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, the affected sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II 18GAX1.16IN PRN SLM NPVC
• 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: 18773781
• MDR Text Key: 336987474
• Report Number: 3002601200-2024-00053
• 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: UNK
• 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,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: Other
• 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: 02/23/2024
• Supplement Dates Manufacturer Received: 02/05/2024; 05/15/2024
• Supplement Dates FDA Received: 02/26/2024; 05/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1