MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOG BC BLU 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 382523

Device Problem Break (1069)

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

Event Date 02/09/2024

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.E1.Address information was not provided, therefore, xx was used as a place holder.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported that bd insyte autog bc blu 22ga x 1.0in "catheter broke." the following information was provided by the initial reporter: "the catheters are splitting, missing or breaking.".

Manufacturer Narrative

Investigation results: the complaint that the catheters are splitting, missing or breaking could not be confirmed from the samples that were provided for investigation.One retracted needle and two 22g insyte autoguard catheters from lot: 3311140 were provided for investigation.A functional test and microscopic examination revealed no leaks, splits, or breaks.Although the returned samples and manufacturing records do not support the complainant¿s description of the reported event, the complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

Event Description

No additional information.

• Brand Name: BD INSYTE AUTOG BC BLU 22GA 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: 18833444
• MDR Text Key: 337238532
• Report Number: 1710034-2024-00157
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: (01)00382903825233
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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: 382523
• Device Lot Number: 3311140
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1