MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Model Number	381233
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that insyte pnk 20ga x 1.0in sheath split.This occurred on 50 occasions.The following information was provided by the initial reporter: material no: 381233, batch no: unknown.It was reported that the sheath splits after catheter is inserted.Complaint: the sheath the needle resides in until the catheter is inserted split.She said the tech described it as beveling or flowering out.
Event or Problem Description
It was reported that insyte pnk 20ga x 1.0in sheath split.This occurred on 50 occasions.The following information was provided by the initial reporter: material no: 381233 batch no: unknown.It was reported that the sheath splits after catheter is inserted.Complaint: the sheath the needle resides in until the catheter is inserted split.She said the tech described it as beveling or flowering out.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated as the lot number is unknown.

• Brand Name: INSYTE PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11143576
• Report Number: 8041187-2021-00013
• Device Sequence Number: 16349782
• Product Code: FOZ
• UDI-Device Identifier: 30382903812333
• UDI-Public: 30382903812333
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (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): 02/11/2021

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 Model Number: 381233
• Device Catalogue Number: 381233
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 01/09/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1