MAUDE Adverse Event Report: NULL PORTEX SPINAL SINGLE SHOT TRAYS; ANESTHESIA CONDUCTION NEEDLE

Catalog Number NEPI-49663C-25

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

Udi unknown.No information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported that during routine spinal for primary c-section, the spinal needle from the replacement kit broke and a portion remained inside the patient's back.This was noted after the placement of the spinal during the c-section.The surgeon and patient were informed.X-rays were obtained showing the needle.Neurosurgery was consulted.Ct obtained for better resolution of needle.Patient remained asymptomatic.Decision was made to leave fragment in patient.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation was completed.No product was returned for investigation.The cause of the reported problem could not be determined.A dhr (device history review) was performed and no problems or issues were identified during this dhr review.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 if additional reportable information becomes available.

• Brand Name: PORTEX SPINAL SINGLE SHOT TRAYS
• Type of Device: ANESTHESIA CONDUCTION NEEDLE
• Manufacturer (Section G): NULL
• MDR Report Key: 15851866
• MDR Text Key: 304182641
• Report Number: 3012307300-2022-27443
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NEPI-49663C-25
• Device Lot Number: 4290806
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Race: White