MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD; INTERVASCULAR CATHETER

Catalog Number	381544
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: 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 the 18g x 1.16in (1.3 x 30 mm) insyte autoguard experienced catheter kinking/bent during infusion during use.The following information was provided by the initial reporter: material no: 381544, batch no: 7201997.Event description: difficulty threading the catheter.Could not treat because catheter would not flush due to bending.Customer confirmed bending occurred during placement.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received a 18 gauge insyte autoguard unit from lo 7201997 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed no kinks, bends or cuts in the catheter tubing.Based off the visual inspection the engineer was unable to verify the reported defect.Since no kinks or bends were observed a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.H3 other text : see section h.10.
Event or Problem Description
It was reported that the 18g x 1.16in (1.3 x 30 mm) insyte autoguard experienced catheter kinking/bent during infusion during use.The following information was provided by the initial reporter: material no: 381544, batch no: 7201997.Event description: difficulty threading the catheter.Could not treat because catheter would not flush due to bending.Customer confirmed bending occurred during placement.

• Brand Name: 18G X 1.16IN (1.3 X 30 MM) INSYTE AUTOGUARD
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8859773
• Report Number: 1710034-2019-00849
• Device Sequence Number: 16221080
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• 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): 08/30/2019

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: 06/30/2020
• Device Catalogue Number: 381544
• Device Lot Number: 7201997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/30/2019
• 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