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

Model Number 381234

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation (2443)

Event Date 08/25/2020

Event Type  Injury  

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 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.

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 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
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10797572
• MDR Text Key: 215017871
• Report Number: 9610048-2020-00150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 9297881
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/14/2020
• Initial Date FDA Received: 11/06/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention