MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC PNK 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 382533

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/14/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte autog bc pnk 20ga x 1.0in catheter contained a break.The following information was provided via medwatch: the iv needle was taken out of the packaging and the reservoir was slightly moved to loosen up.Registered nurse (rn) noticed that the tip of the catheter was almost breaking off and hanging by a thread.Rn disposed of damaged catheter.

Manufacturer Narrative

A.2.Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.E4.The initial reporter also notified the fda november of 2023.Medwatch report is (b)(4).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Investigation results: a device history record review was completed by our quality engineer team for provided material number 382533 and lot number 3142661.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.Complaints received for this device and reported condition will continue to be tracked and trended.

Event Description

Additional information: describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm or injury reported.

• Brand Name: BD INSYTE AUTOG BC PNK 20GA X 1.0IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18906048
• MDR Text Key: 337689841
• Report Number: 1710034-2024-00185
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825332
• UDI-Public: (01)00382903825332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Device Operator: Other
• Device Catalogue Number: 382533
• Device Lot Number: 3142661
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/14/2024
• Supplement Dates Manufacturer Received: 03/21/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR