MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD¿ INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Catalog Number	382537
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.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It was reported that the needle of a bd¿ insyte autoguard bc was retracted about an hour after activating safety mechanism.The following information was provided by the initial reporter: ¿the product did not retract, but then it retracted after about an hour (it was just sitting there and retracted on its own) it looks like there may be some warping on the plastic next to the spring".
Additional Manufacturer Narrative
H.6.Investigation: dhr review was not performed as the lot number associated with this account was unknown.Received one 20ga iag needle-barrel assembly and a needle cover.The needle was received fully retracted inside the safety barrel and the catheter assembly was not returned for evaluation.The needle was pushed to the out position and then the white button was depressed.Although the needle retracted, retraction was slow.Upon further examination it was detected there was damage on the nose of the hub.The damage observed on would get caught up on the grip causing slow retraction.Although a definite source that caused the damage observed on the hub (which slowed retraction) could not be determined, the failure was manufactured related and it was produced during the assembly process of the unit by a misalignment issue triggered by normal tear/wear of the machine.
Event or Problem Description
It was reported that the needle of a bd¿ insyte autoguard bc was retracted about an hour after activating safety mechanism.The following information was provided by the initial reporter: ¿ the product did not retract, but then it retracted after about an hour (it was just sitting there and retracted on its own) it looks like there may be some warping on the plastic next to the spring.¿.

• Brand Name: BD¿ 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: 8474516
• Report Number: 1710034-2019-00362
• Device Sequence Number: 1018984
• Product Code: FOZ
• UDI-Device Identifier: 30382903825371
• UDI-Public: 30382903825371
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/03/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 04/02/2019
• Supplement Report FDA Received Date: 05/03/2019
• 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