MAUDE Adverse Event Report: PAJUNK GMBH MEDIZINTECHNOLOGIE E CATH; PERIPHERAL NERVE BLOCK, CONTINUOUS

Model Number 211185-40E

Device Problems Fracture (1260); Material Split, Cut or Torn (4008)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 08/19/2018

Event Type  Injury  

Manufacturer Narrative

Currently the data is poor and the device has not been returned/ analysed.As soon as further data will be available a follow up report will be sent in to the agency.

Event Description

Irn# (b)(4).E-cath was pulled last night from a cognitively impaired patient.The catheter was used on a supraclavicular block that was indwelling for 6 days.It was reported to dr.(b)(6) that the catheter was an "easy out" upon removal.Upon removal, it was observed that the tip may be missing and a picture was taken and sent to dr.(b)(6).(picture will be forwarded on as well.).Catheter was thrown away and is not available for inspection.In looking at the picture it appears that not only is the tip missing but the catheter appears to have been stretched as well.At the time of this reporting the patient is said to be asymptomatic.Dr.(b)(6) has requested additional details about the catheter material (whether or not inert) and recommendations on next steps and whether removal of tip need be attempted.

Manufacturer Narrative

Based on risk assessment and clinical evaluation report this file is considered as closed.Attachment: [2018-09-20_577_291-18_9611612-2018-00034fu_report.Pdf].

Event Description

Irn# (b)(4).E-cath was pulled last night from a cognitively impaired patient.The catheter was used on a supraclavicular block that was indwelling for 6 days.It was reported to dr.(b)(6) that the catheter was an "easy out" upon removal.Upon removal, it was observed that the tip may be missing and a picture was taken and sent to dr.(b)(6).(picture will be forwarded on as well.).Catheter was thrown away and is not available for inspection.In looking at the picture it appears that not only is the tip missing but the catheter appears to have been stretched as well.At the time of this reporting the patient is said to be asymptomatic.Dr.(b)(6) has requested additional details about the catheter material (whether or not inert) and recommendations on next steps and whether removal of tip need be attempted.

• Brand Name: E CATH
• Type of Device: PERIPHERAL NERVE BLOCK, CONTINUOUS
• Manufacturer (Section D): PAJUNK GMBH MEDIZINTECHNOLOGIE; karl-hall-str. 1; tuttlinger str. 7; geisingen, baden-wuerttemberg 78187 ; GM 78187
• MDR Report Key: 7808036
• MDR Text Key: 117959413
• Report Number: 9611612-2018-00034
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 14048223025298
• UDI-Public: 14048223025298
• Combination Product (y/n): N
• PMA/PMN Number: K152952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 211185-40E
• Device Catalogue Number: 211185-40E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other