MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE-W WINGED GN 18GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381344
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/29/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that insyte-w winged gn 18ga x 1.16in leaked during use.The following information was provided by the initial reporter: patient was being reperfused on the day of the incident.I put in the catheter, plugged in my infusion line and when i turned on, i saw a large amount of blood flowing through the catheter.The blood was slit along the length between the wings of the device.
Event or Problem Description
It was reported that insyte-w winged gn 18ga x 1.16in leaked during use.The following information was provided by the initial reporter: patient was being reperfused on the day of the incident.I put in the catheter, plugged in my infusion line and when i turned on, i saw a large amount of blood flowing through the catheter.The blood was slit along the length between the wings of the device.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: INSYTE-W WINGED GN 18GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10069878
• Report Number: 8041187-2020-00273
• Device Sequence Number: 3924043
• Product Code: FOZ
• UDI-Device Identifier: 30382903813446
• UDI-Public: 30382903813446
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151698
• 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): 07/27/2020

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: 12/31/2022
• Device Model Number: 381344
• Device Catalogue Number: 381344
• Device Lot Number: 7356244
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/29/2020
• Supplement Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/19/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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