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 Retraction Problem (1536)

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

Event Date 02/13/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autog bc blu 22ga x 1.0in experienced needle retraction failure.The following information was provided by the initial reporter: it was reported by the customer reported needle did not retract fully increasing the risk to the nurse suffering a needle stick.Needle did not retract fully.Customer response on (b)(6) 2024: no injury, did happen during patient use.

Manufacturer Narrative

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: the complaint of the needle not retracting could not be confirmed from the 41 representative 22g insyte autoguard units that were provided for investigation.Each unit was received in sealed packaging.A functional test revealed that each needle fully retracted when the safety mechanism was activated.Although the representative 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.Complaints received for this device and reported condition will continue to be tracked and trended.

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: 18825962
• MDR Text Key: 336776058
• Report Number: 1710034-2024-00151
• 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
• Report Date: 02/16/2024

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: 3251069
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2024
• Initial Date FDA Received: 03/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1