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

Model Number	381234
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).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 bd insyte iv catheter 20ga 1.16in separated after placement and had flashback.The following information was provided by the initial reporter: "after the device has been placed, there was not blood reflux.Removing the device they saw there was the distal part of the catheter missing (0,5 cm) and the catheter was damaged.The missing part has been detected by echography in the soft tissue.Patient has a surgical consultation but it was decided not to remove the broken part because it is inert in the soft tissue.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 4/14/2020.H.6.Investigation: one representative sample was received by our quality team for evaluation.The sample was subjected to visual inspection and flashback testing.No abnormality was observed; therefore, the incident could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Due to no abnormality observed during investigation, a root cause could not be determined.
Event or Problem Description
It was reported that bd insyte¿ iv catheter 20ga 1.16in separated after placement and had flashback.The following information was provided by the initial reporter: "after the device has been placed, there was not blood reflux.Removing the device they saw there was the distal part of the catheter missing (0,5 cm) and the catheter was damaged.The missing part has been detected by echography in the soft tissue.Patient has a surgical consultation but it was decided not to remove the broken part because it is inert in the soft tissue.".

• Brand Name: BD INSYTE IV CATHETER 20GA 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: 9930574
• Report Number: 9610048-2020-00053
• Device Sequence Number: 19537373
• Product Code: FOZ
• UDI-Device Identifier: 30382903812340
• UDI-Public: 30382903812340
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 07/29/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2024
• Device Model Number: 381234
• Device Catalogue Number: 381234
• Device Lot Number: 9024654
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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: Other