MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE INTRALONG; CATHETER ANASETHESIA CONDUCTION, SPINAL

Model Number 31151-30GS

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/20/2017

Event Type  Injury  

Manufacturer Narrative

Event took place in (b)(6) and has been reported through (b)(6) distributor.Based on risk assessment and clinical evaluation file is considered as closed.

Event Description

(b)(4).Summarizing tentative translation from initial reporter´s narrative: the catheter is very elastic but gently pulled out until it drops the skin with a slight odor.I think it looks like it's broken at the end and contacts the anesthetist.After completion of the wake up, the patient should be ct scanned for further planning." the patient got the catheter removed operatively.

• Brand Name: INTRALONG
• Type of Device: CATHETER ANASETHESIA CONDUCTION, SPINAL
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer (Section G): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• Manufacturer Contact: christian quass ; karl-hall-str. 1; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7057665
• MDR Text Key: 92851760
• Report Number: 9611612-2017-00015
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K082183
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 09/01/2021
• Device Model Number: 31151-30GS
• Device Catalogue Number: 31151-30GS
• Device Lot Number: 1175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2016
• 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): Other