MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD BC PRO WINGED H5323-2 CATHETER; INTRAVASCULAR CATHETER

Catalog Number	392623
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro winged h5323-2 catheter was loose and dislodged during use.Additionally, the tube was also "too long".The following information was provided by the initial reporter: "i'm not sure if i'm doing this correctly, but i have a complaint from a nurse that cared for me while i was hospitalized this past weekend.The nurse mentioned the following when she was inserting the insyte autoguard bc pro winged into me: "when holding the catheter in place for insertion, the catheter is very loose and flimsy and dislodges from the device easily." she also mentioned the tube is too long".
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received two photos displaying a unit with a blue adapter with a connection at the luer end of the adapter.The adapter is secured with a transparent dressing.There is also another miscellaneous unit with a red circle around it and secured with dressing.Another photo displays the top web of an opened package from ref.392623, lot 9326710.Through the visual examination, the photo revealed no visible damage.Therefore, the photo provided for this incident did not present sufficient evidence to identify or confirm the alleged failure or to establish a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of this batch.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc pro winged h5323-2 catheter was loose and dislodged during use.Additionally, the tube was also "too long".The following information was provided by the initial reporter: "i'm not sure if i'm doing this correctly, but i have a complaint from a nurse that cared for me while i was hospitalized this past weekend.The nurse mentioned the following when she was inserting the insyte autoguard bc pro winged into me: "when holding the catheter in place for insertion, the catheter is very loose and flimsy and dislodges from the device easily." she also mentioned the tube is too long".

• Brand Name: BD INSYTE AUTOGUARD BC PRO WINGED H5323-2 CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10744325
• Report Number: 1710034-2020-00691
• Device Sequence Number: 3204455
• Product Code: FOZ
• UDI-Device Identifier: 00382903926237
• UDI-Public: 00382903926237
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 392623
• Device Lot Number: 9326710
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1