MAUDE Adverse Event Report: BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD DORA BAIN FISTUAL NEEDLE; NEEDLE, FISTULA

Lot Number ,202002010545

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/01/2021

Event Type  Injury  

Event Description

Dora bain fistual needles, lot#: 202002010545.Caps on the lines attached to the needles are often loose or completely off, causing unintended blood loss immediately after cannulation.Patients are complaining that these needles feel dull upon insertion into access.Also, techs are complaining that there isn't a good way/ place to hold / pull / remove needles from access making it extremely awkward / difficult and causing a large amount of blood leakage upon removal.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: DORA BAIN FISTUAL NEEDLE
• Type of Device: NEEDLE, FISTULA
• Manufacturer (Section D): BAIN MEDICAL EQUIPMENT(GUANGZHOU) CO., LTD
• MDR Report Key: 17536476
• MDR Text Key: 321148525
• Report Number: MW5143364
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2021

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?: No
• Device Lot Number: ,202002010545
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1