MAUDE Adverse Event Report: BD (SUZHOU) BD UNKNOWN; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Complete Blockage (1094)

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

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd unknown had a needle defect other the following information was provided by the initial reporter; patient receiving iv fluids, needle core stuck, unable to give fluids.

Manufacturer Narrative

A complaint history review cannot be performed as no material and batch/lot number was provided.A device history record(dhr) review could not be performed as no material and batch/lot number was made available for this reported event.A retain sample analysis review could not be performed as no material and batch/lot number was made available for this reported event.Ar-code--a review of the applicable  risk documentation indicates that the potential risk of the reported event was assessed appropriately in the risk management documentation.Root cause couldn't be determined due to unavailability of sample, material and batch/lot number information.H3 other text: see narrative.

Event Description

No additional information provided.

• Brand Name: BD UNKNOWN
• 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: 18275892
• MDR Text Key: 329847349
• Report Number: 3014704491-2023-00797
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 04/11/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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