MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381234
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Inflammation (2443)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that insyte pnk 20ga x 1.16in was used and caused redness, swelling, and pain and ultrasonography was performed.The following information was provided by the initial reporter: when the indwelling needle was used to the 3rd day, the local redness, swelling and pain were obvious, with purulent secretions.B - ultrasonography was performed after the diagnosis of "superficial venous thrombosis".Anticoagulant treatment for 3 months.Analysis: it is related to the material of indwelling needle.
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.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.The sterilization records were reviewed, and no abnormalities were observed.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that insyte pnk 20ga x 1.16in was used and caused redness, swelling, and pain and ultrasonography was performed.The following information was provided by the initial reporter: when the indwelling needle was used to the 3rd day, the local redness, swelling and pain were obvious, with purulent secretions.B - ultrasonography was performed after the diagnosis of "superficial venous thrombosis".Anticoagulant treatment for 3 months.Analysis: it is related to the material of indwelling needle.

• Brand Name: INSYTE PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10797572
• Report Number: 9610048-2020-00150
• Device Sequence Number: 17114654
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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?: No
• Operator of Device: Other
• Device Expiration Date: 10/31/2024
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 9297881
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/06/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: Required Intervention