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

Model Number	211185-40E
Medical Device Problem Codes	Fracture (1260); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Date of Event	08/19/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 9611612-2018-00034
• Device Sequence Number: 11130038
• Product Code: BSO
• UDI-Device Identifier: 14048223025298
• UDI-Public: 14048223025298
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K152952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 211185-40E
• Device Catalogue Number: 211185-40E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other