MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ANGIOCATH AUTOGUARD PNK 20GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381703
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 angiocath autoguard pnk 20ga x 1.16in catheter was discolored.This was discovered during use.The following information was provided by the initial reporter: material no.381703 batch no.Unknown (reported: 606394938).It was reported that catheter is no longer transparent, making it difficult to complete the treatment.Event description per email states: pink plastic catheter that remains in the pt's arm is no longer transparent, you cannot see the blood flash making it very hard to tell whether catheter is in the vein.
Additional Manufacturer Narrative
H.6.Investigation summary: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.H3 other text : see h.10.
Event or Problem Description
It was reported that angiocath autoguard pnk 20ga x 1.16in catheter was discolored.This was discovered during use.The following information was provided by the initial reporter: material no.381703, batch no.Unknown (reported: 606394938).It was reported that catheter is no longer transparent, making it difficult to complete the treatment.Event description per email states: pink plastic catheter that remains in the pt's arm is no longer transparent, you cannot see the blood flash making it very hard to tell whether catheter is in the vein.

• Brand Name: ANGIOCATH AUTOGUARD PNK 20GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10561084
• Report Number: 1710034-2020-00591
• Device Sequence Number: 13562243
• Product Code: FOZ
• UDI-Device Identifier: 30382903817031
• UDI-Public: 30382903817031
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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: 02/28/2019
• Device Model Number: 381703
• Device Catalogue Number: 381703
• Device Lot Number: 6063949
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/30/2020
• Supplement Date Received by Manufacturer: 08/30/2020
• Initial Report FDA Received Date: 09/21/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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