MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ WINGED GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Catalog Number	381544
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); Swelling (2091)
Date of Event	05/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that upon insertion the catheter split and bent inside patient with a bd insyte¿ autoguard¿ winged gn 18 ga x 1.16 in.The following information was provided by the initial reporter: it was reported that when inserting cathlon into patient, needle pieced through the plastic cathlon and the cathlon split/bent inside the patient, causing bleeding, swelling and pain.This happened during an emergency event.
Event or Problem Description
It was reported that upon insertion the catheter split and bent inside patient with a bd insyte¿ autoguard¿ winged gn 18ga x 1.16in.The following information was provided by the initial reporter: it was reported that when inserting cathlon into patient, needle pieced through the plastic cathlon and the cathlon split/bent inside the patient, causing bleeding, swelling and pain.This happened during an emergency event.
Additional Manufacturer Narrative
Investigation summary: dhr review was performed on lot number 8278868; the lot number was built on afa line 6 from 29oct18 thru 31oct18.Packaged on packaging line 10 from 01nov18 thru 02nov18 for a quantity of 134,010 units.Review of dhr revealed all required challenge samples, set-up and in process testing was performed in accordance with the quality plans.Review disclosed no reject activity findings throughout the build of this lot that would impact the outcome of the quality of the product relevant to the defect stated in the pir.No physical samples were not received for testing and evaluation; three photos were provided for evaluation of this incident.Photo one displayed a18 iag winged adapter revealing the needle had pierced thru the catheter tubing near the tip.There were bodily fluids in the catheter tubing and the adapter body.Photo two displayed the same as photo one.Photo three displayed the same as photo one and two.Visual/microscopic evaluation: based on the evaluation of the submitted photos the reported defects needle thru catheter and catheter kink/bent were confirmed conclusion: undetermined ¿ the defect needle thru catheter and catheter kink/bent were confirmed with the submitted photos.The defect associated with this incident report was caused by the cannula spearing the catheter wall.Bodily fluids observed within the unit indicate the needle and catheter were correctly assembled at the time of use.The condition of the unit in the photo; the catheter would not be able to penetrate the skin.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8663584
• Report Number: 1710034-2019-00584
• Device Sequence Number: 2256441
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 09/30/2021
• Device Catalogue Number: 381544
• Device Lot Number: 8278868
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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