MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20G X 1.88IN (1.1 X 48 MM) INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Catalog Number	382537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that two 20g x 1.88in (1.1 x 48 mm) insyte autoguard bc experienced cannula breakage.The following information was provided by the initial reporter: material no: 382537, batch no: unknown.Per customer email: i was using this catheter to place an ultrasound guided iv last week and this little plastic piece became stuck in the base of the luer lock hub of the catheter.It appears to be part of the retracting mechanism.I tried again with a second ¿bd insyte autogard bc¿ and the problem happened again.I have used this same type of iv catheter many, many times before and never seen this issue before.
Event or Problem Description
It was reported that two 20g x 1.88in (1.1 x 48 mm) insyte autoguard bc experienced cannula breakage.The following information was provided by the initial reporter: material no: 382537 batch no: unknown.Per customer email: i was using this catheter to place an ultrasound guided iv last week and this little plastic piece became stuck in the base of the luer lock hub of the catheter.It appears to be part of the retracting mechanism.I tried again with a second ¿bd insyte autogard bc¿ and the problem happened again.I have used this same type of iv catheter many, many times before and never seen this issue before.
Additional Manufacturer Narrative
H.6.Investigation: dhr could not be conducted because a lot number was not provided.¿ although units were not returned, one photo was provided for evaluation of this incident.O photo shows a view of an undamaged top web (label) side of a blister pack from a 20ga bd insyte autoguard bc iv catheter, ref.382537.The lot number was not visible in the photo.O the photo also shown the iv catheter in portions: 1st portion was the actuator (portion from within the adapter).2nd portion was the catheter/adapter assembly.3rd portion was the needle/hub assembly which was fully retracted with the safety shield (barrel).**note that all three portions had traces of media present.Visual/microscopic evaluation: ¿ observations of the photo revealed that the actuator was removed from within the adapter of the iv catheter unit; thus confirming the defect of catheter defective / damaged ¿ although the photo provided for this incident presented sufficient evidence to identify or confirm the reported failure, it did not provide sufficient evident to establish a definite root cause.

• Brand Name: 20G X 1.88IN (1.1 X 48 MM) INSYTE AUTOGUARD BC
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8575948
• Report Number: 1710034-2019-00494
• Device Sequence Number: 2359752
• Product Code: FOZ
• UDI-Device Identifier: 30382903825371
• UDI-Public: 30382903825371
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• 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): 05/17/2019

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 Catalogue Number: 382537
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 05/02/2019
• Supplement Report FDA Received Date: 05/17/2019
• 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