MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHILEDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Fail-Safe Design Failure (1222)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.

Event Description

It was reported that the safety mechanism on an unspecified bd insyte¿ autoguard¿ shileded iv catheter did not function correctly, leaving the needle exposed.There was no report of injury or medical interventions.

Manufacturer Narrative

Supplemental for correction of bd awareness date.Initial mdr reported the "date received by manufacturer" as 08/28/17 but should have been reported as 08/21/2017.

Manufacturer Narrative

Investigation: received one (1) iag used unit from an unknown lot number, the unit consisted of a needle/barrel assembly and a needle cover.The unit was received with the needle entirely out of the safety barrel and the white button was not pressed, there was no damage observed to the spring, needle hub or grip and there were no missing components.Traces of blood were visible in the needle hub.Preceded to perform the functional test by pushing the white button, the needle did no retract and the button could not be pushed.Observed there were traces of cured adhesive in between the white button and the grip of the assembly.The defect of needle retraction failure as stated in the subject of the pir was confirmed.Traces of cured adhesive in between the white button and the grip of the assembly prevented the white button from being depressed therefore, the needle did not retract.The cured adhesive observed in between the white button and the grip of the assembly was physical evidence to confirm and support the manufacturing process related issues for the defect.

• Brand Name: UNSPECIFIED BD INSYTE¿ AUTOGUARD¿ SHILEDED IV CATHETER
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6880067
• MDR Text Key: 87734651
• Report Number: 1710034-2017-00231
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other