MAUDE Adverse Event Report: INTRODUCER INTROSYTE-N 1.9F 1.9CM; CATHETER

Catalog Number	384021
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm sheath did not split as intended.The following information was provided by the initial reporter: material no: 384021, batch no: 0238454.It was reported that while peeling away the introducer did not fully peel off the line at the very tip leaving a rough edge.  verbatim: unfortunately we had another event in the nicu with the 1.9fr 26g introducer date of incident: (b)(6) 2021.Any injuries and/or harm? no, provider was able to remove from patient and place picc using new introducer what is the issue you experienced? introducer inserted and line was threading in and infant moved and introducer came out from the skin.Decision made to peel away the introducer and attempt to continue threading of picc line.While peeling away the introducer did not fully peel off the line at the very tip leaving a rough edge.The line came out of the vein and placement aborted.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm sheath did not split as intended.The following information was provided by the initial reporter: material no: 384021 batch no: 0238454.It was reported that while peeling away the introducer did not fully peel off the line at the very tip leaving a rough edge.  verbatim: unfortunately we had another event in the nicu with the 1.9fr 26g introducer date of incident: (b)(6) 2021.Any injuries and/or harm? no, provider was able to remove from patient and place picc using new introducer.What is the issue you experienced? introducer inserted and line was threading in and infant moved and introducer came out from the skin.Decision made to peel away the introducer and attempt to continue threading of picc line.While peeling away the introducer did not fully peel off the line at the very tip leaving a rough edge.The line came out of the vein and placement aborted.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

• Brand Name: INTRODUCER INTROSYTE-N 1.9F 1.9CM
• Common Device Name: CATHETER
• MDR Report Key: 11881442
• Report Number: 1710034-2021-00437
• Device Sequence Number: 11103396
• Product Code: FOZ
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 384021
• Device Lot Number: 0238454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 08/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1