MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE SONOLONG ECHO NANOLINE; PERIPHERAL NERVE BLOCK KIT

Model Number 521185-31C

Device Problems Fracture (1260); Device Handling Problem (3265)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/26/2017

Event Type  Injury  

Event Description

(b)(4).From initial reporter´s narrative: (b)(6) year old child booked for modified raavitch repair.Preop consented for ga and bilateral paravertebral catheters for la infusion.No problems at induction and child turned into lateral position sbyb performed and left paravertebral catheter inserted under full aseptic precautions using 100mm sonoecho nerve block kit.Catheter was tunnelled under the skin and whilst being withdrawn to appropriate length it was noted to be sheared at 9 cm mark.Attempt to find the catheter by myself and mr (b)(6) failed and it was decided after discussion with dr (b)(6) to do a ct scan and locate the catheter position.Family was informed by myself and mr (b)(6) and all options given to them.Consent was obtained to surgically remove the sheared catheter if possible.The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion following further discussions with the family it was decided to go ahead with original surgical procedure.The various options of pain relief were considered and it was decided to insert bilateral paravertebral catheters which was uneventful surgery went smoothly and child was extubated at the end and transferred back to ic details of injury (to patient, carer or healthcare professional): consent was obtained to surgically remove the sheared catheter if possible.The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion.Action taken (includes any action by patient, carer or healthcare professional, or by the manufacturer or supplier) consent was obtained to surgically remove the sheared catheter if possible.The catheter location was identified under ct and surgically removed by a small incision in the back at the original entry point of insertion.

• Brand Name: SONOLONG ECHO NANOLINE
• Type of Device: PERIPHERAL NERVE BLOCK KIT
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, 78187 ; GM 78187
• MDR Report Key: 6829962
• MDR Text Key: 83962680
• Report Number: 9611612-2017-00007
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 02/28/2019
• Device Model Number: 521185-31C
• Device Catalogue Number: 521185-31C
• Device Lot Number: 1056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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