MAUDE Adverse Event Report: BECTON DICKINSON BD INSYTE-W WINGED PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number	381333
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte-w winged pnk 20ga x 1.0in had foreign matter.It was reported by customer that they called into the queue and stated there was a clear jelly-like substance coming from the tip of the catheter (very small amount and sticky).Happened two times.Did not use on pt.Verbatim: customer called into the queue and stated there was a clear jelly-like substance coming from the tip of the catheter (very small amount and sticky).Happened two times.Did not use on pt.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.No photo/sample was received for further investigation.Root cause could not be determined.As current control, there is an outgoing visual inspection in place to check for excessive silicone on catheter tubing.
Event or Problem Description
Material #:381333, batch#:3311962.It was reported by customer that they called into the queue and stated there was a clear jelly like substance coming from the tip of the catheter (very small amount and sticky).Happened two times.Did not use on pt.Verbatim: customer called into the queue and stated there was a clear jelly like substance coming from the tip of the catheter (very small amount and sticky).Happened two times.Did not use on pt.

• Brand Name: BD INSYTE-W WINGED PNK 20GA X 1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19951024
• Report Number: 2243072-2024-00877
• Device Sequence Number: 8898162
• Product Code: FOZ
• UDI-Device Identifier: 00382903813339
• UDI-Public: (01)00382903813339
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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 Catalogue Number: 381333
• Device Lot Number: 3311962
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown