MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL LTD., PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS; CATHETER, CONDUCTION, ANESTHETIC

Catalog Number 100/382/118

Device Problem Material Fragmentation (1261)

Patient Problems Injury (2348); Device Embedded In Tissue or Plaque (3165)

Event Date 06/22/2016

Event Type  Injury  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

The event occurred in (b)(6).The supplier reported on behalf of the patient that after a procedure was completed on the patient, clinical staff tried to remove the portex® csecure® spinal and epidural needle catheter, and it broke with a 2cm piece remaining in the patient's muscle.There was follow up information that stated the doctors found the piece and removed it from the patient.Unknown patients condition at this time.

• Brand Name: PORTEX® CSECURE® SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL LTD.,; unit 4 bradwood court st.; 1 crispin way; rossendale, BB4 4 PW; UK BB4 4PW
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.,; unit 4 bradwood court st.; 1 crispin way; rossendale, BB4 4 PW; UK BB4 4PW
• Manufacturer Contact: lisa perz ; 1265 grey fox rd; st. paul, MN 55112 ; 7633833074
• MDR Report Key: 5806582
• MDR Text Key: 49913164
• Report Number: 2183502-2016-01533
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K062005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 100/382/118
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2016
• 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
• Patient Outcome(s): Required Intervention