MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W IV CATHETER WITH WINGS 20GA 1.16IN (1.1 X 30 MM); INTRAVASCULAR CATHETER

Catalog Number	381334
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/09/2020
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.
Event or Problem Description
It was reported that the needle of the insyte-w winged pnk 20ga x 1.16in pierced the catheter during use.The following information was provided by the initial reporter: verbatim: the catheter is damaged by the needle.The tubing that is pierced with the needle before use.The tubing that bends in the patient's vein during the examination causing undesirable pressure limits when using injection pumps.
Additional Manufacturer Narrative
This complaint was completed using the incorrect reportability rationale and is no longer reportable.Because the defect was noted prior to use rendering the device unusable, it is not considered a reportable event.This complaint should therefore be disregarded.The following information has been corrected: b.5.Describe event or problem: it was reported that the needle of the insyte-w winged pnk 20ga x 1.16in pierced the catheter prior to use.The following information was provided by the initial reporter: verbatim: the catheter is damaged by the needle.The tubing that is pierced with the needle before use.The tubing that bends in the patient's vein during the examination causing undesirable pressure limits when using injection pumps.
Event or Problem Description
It was reported that the needle of the insyte-w winged pnk 20ga x 1.16in pierced the catheter prior to use.The following information was provided by the initial reporter: verbatim: the catheter is damaged by the needle.The tubing that is pierced with the needle before use.The tubing that bends in the patient's vein during the examination causing undesirable pressure limits when using injection pumps.

• Brand Name: BD INSYTE-W IV CATHETER WITH WINGS 20GA 1.16IN (1.1 X 30 MM)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9644554
• Report Number: 8041187-2020-00027
• Device Sequence Number: 11386550
• Product Code: FOZ
• UDI-Device Identifier: 00382903813346
• UDI-Public: 00382903813346
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Catalogue Number: 381334
• Device Lot Number: 9279954
• Initial Date Received by Manufacturer: 01/09/2020
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 03/17/2020
• 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