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

Catalog Number 383028

Device Problem Collapse (1099)

Patient Problem Pain (1994)

Event Date 11/28/2023

Event Type  malfunction  

Event Description

It was reported that bd intima-ii catheter buckled.The following information was provided by the initial reporter, translated from chinese to english: at 09:00 on (b)(6) 2023 while administering an antimicrobial drug set intravenously with an indwelling needle, the puncture indwelling needle hose buckled, causing the vessel to rupture, and re-puncturing causing the patient pain.

Manufacturer Narrative

The lot number 2753975 provided has not been found and cannot be verified.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

A complaint history check was unable to be performed since no lot/batch number was provided.A device history review was unable to be performed since no lot/batch number was provided.A retain sample analysis could not be performed as no batch/lot number was made available for this reported event.R-code--a review of the applicable  fmea/eura indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation-s.Davidson.Root cause couldn't be determined due to unavailability of sample and batch/lot number information.

Event Description

No additional information provided.

• Brand Name: BD INTIMA-II 24GAX0.75IN 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: 18906053
• MDR Text Key: 337776708
• Report Number: 3002601200-2024-00085
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830282
• UDI-Public: (01)00382903830282
• 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: 04/05/2024

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: 383028
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1