MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC, SUBSIDIARY TELEFLEX INC SUREBLOCK SPINAL ANESTHESIA KIT; NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Model Number ASA-25090-SB

Patient Problems Needle Stick/Puncture (2462); Foreign Body In Patient (2687)

Event Date 04/10/2024

Event Type  Injury  

Event Description

When spinal needle removed (c-section prep), approximately 4-5 cm of needle missing, broken off in patient.Required new spinal.Removal done of the rfb (needle) after delivery of the baby.Separate procedure.Needle: sprotte spinal needle: 25 ga x 3-1/2 (90mm) with 21 ga x 30mm.

• Brand Name: SUREBLOCK SPINAL ANESTHESIA KIT
• Type of Device: NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
• Manufacturer (Section D): ARROW INTERNATIONAL LLC, SUBSIDIARY TELEFLEX INC; morrisville NC 27560
• MDR Report Key: 19184332
• MDR Text Key: 341203370
• Report Number: MW5154303
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/22/2024

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 Model Number: ASA-25090-SB
• Device Lot Number: 33F23H0235
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Female
• Patient Weight: 125 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White