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	08/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.The customer's address is unknown.(b)(6) usa has been used as a default.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: 6063949.It was reported that the pink cannula is opaque and making unable to see if iv inserted properly.
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.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: 6063949.It was reported that the pink cannula is opaque and making unable to see if iv inserted properly.

• 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: 10557411
• Report Number: 1710034-2020-00596
• Device Sequence Number: 13562084
• 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: foreign,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 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: 09/18/2020
• 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