MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 18G X 1.88IN (1.3 X 48 MM) INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Catalog Number	382547
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an unspecified number of 18g x 1.88in (1.3 x 48 mm) insyte autoguard bc experienced catheter adapter/connector/hub cracked/broken which was noted prior to use.The following information was provided by the initial reporter: material no: 382547, batch no: unknown.Hole in the green part of the hub.
Additional Manufacturer Narrative
Received a 18ga iag bc catheter-adapter assembly along with a piece of top web (packaging) from lot 8170875.A review of the device history record revealed no irregularities during the manufacture of the reported lot.Visual examination: the received unit revealed a crack in the adapter body which ran linear with the unit and transposed within the material.Conclusion(s): manufacturing : although a definite source that caused the damage observed on the adapter could not be determined, this could potentially have been caused either due to high air pressure on the rotate gripper transferring the adapter from the escapement to pins or/and low air pressure on the feeder (hopper) : air pressure needs to be altered to allow adjustments due to variation on material.
Event or Problem Description
It was reported that an unspecified number of 18g x 1.88in (1.3 x 48 mm) insyte autoguard bc experienced catheter adapter/connector/hub cracked/broken which was noted prior to use.The following information was provided by the initial reporter: material no: 382547 batch no: unknown.Hole in the green part of the hub.

• Brand Name: 18G X 1.88IN (1.3 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: 9324568
• Report Number: 1710034-2019-01225
• Device Sequence Number: 14169798
• Product Code: FOZ
• UDI-Device Identifier: 30382903825470
• UDI-Public: 30382903825470
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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): 12/18/2019

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: 05/31/2021
• Device Catalogue Number: 382547
• Device Lot Number: 8170875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/30/2019
• Supplement Date Received by Manufacturer: 10/30/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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