MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. IAG BC PRO PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	392533
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter additional phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that iag bc pro pnk 20ga x 1.0in was not working with stabilization device.The following information was provided by the initial reporter: material no: 392533 batch no: 9248850 it was reported: bd insyte¿ autoguard¿ bc pro and bard/bd statlock® iv ultra stabilization device do not seem to be working together.Verbatim: question nurse caller with bd insyte¿ autoguard¿ bc pro using in conjunction with bard/bd statlock® iv ultra stabilization device states nurses in her hospital are losing iv accesses and are frustrated that the two products do not seem to be working together and this is what her hospital has supplied them.Many nurses are trying to put the device on as in the first picture which does not secure the catheter at all.The second picture shows what appears to be the proper way to use it although it's still not all that secure.The catheter still moves under the device and does not appear to actually lock it in place." response asked caller to email me pictures of products and she emailed six photos.
Event or Problem Description
It was reported that iag bc pro pnk 20ga x 1.0in was not working with stabilization device.The following information was provided by the initial reporter: material no: 392533 batch no: 9248850 it was reported: bd insyte¿ autoguard¿ bc pro and bard/bd statlock® iv ultra stabilization device do not seem to be working together.Verbatim: question nurse caller with bd insyte¿ autoguard¿ bc pro using in conjunction with bard/bd statlock® iv ultra stabilization device states nurses in her hospital are losing iv accesses and are frustrated that the two products do not seem to be working together and this is what her hospital has supplied them.Many nurses are trying to put the device on as in the first picture which does not secure the catheter at all.The second picture shows what appears to be the proper way to use it although it's still not all that secure.The catheter still moves under the device and does not appear to actually lock it in place." response asked caller to email me pictures of products and she emailed six photos.
Additional Manufacturer Narrative
H.6.Investigation: our quality engineer inspected the photographs submitted for evaluation.Bd received four photos.Upon inspection of the provided photos no defect was observed in relation to the connection between the two devices.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: IAG BC PRO PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10880935
• Report Number: 1710034-2020-00737
• Device Sequence Number: 546171
• Product Code: FOZ
• UDI-Device Identifier: 00382903925339
• UDI-Public: 00382903925339
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 12/14/2020

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: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 392533
• Device Lot Number: 9248850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/27/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/21/2020
• Supplement Report FDA Received Date: 12/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1