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

Catalog Number 381434

Device Problems Device Operates Differently Than Expected (2913); Protective Measures Problem (3015)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: bd received a total of (b)(4) units from lot number 7227517.All units were received within sealed packages, their components were intact.No mechanical/physical damage was observed to the spring, needle hub or grip.There were no missing components or evidence of glue on the buttons or hubs.The needle covers were removed, manually rotated the catheter tips 360 degrees, the catheter tubing did not ¿candy canned¿.The white buttons were depressed and the needles did retract meeting no resistance.Retraction was successful.No mechanical/physical damage was observed and the units demonstrated a successful retraction when tested in the laboratory environment.Per review of the dhr, it was concluded that all required challenges samples and testing was performed per specification in accordance with the set-up and in process sampling plans.Per review it was noted that there were no reject activity findings throughout the build of this lot that would impact upon the quality of the product.Set-up and in process samples (including but not limited to) for damaged component (grip, button, spring, hub), needle retraction by button activation and adhesive overfilled/drip as well as periodic cleaning/alignment of the glue grippers were performed on various stages throughout the process, all the inspections passed per specifications.No significant discoveries were found.The defect of needle retraction failure as stated in the event description could not be confirmed with the representative units returned for evaluation and testing.Did the evaluation confirm the customer¿s experience with the bd product? no; the defect of needle retraction failure that the customer experienced was not confirmed with the units received for evaluation and testing.Were we able to reproduce the customer's experience with the bd product? no; reproduction of the failure that the customer experienced could not be achieved with the evaluation and testing performed on the units received in the laboratory environment.Was the device used for treatment or diagnosis? treatment.Root cause: relationship of device to the reported incident: indeterminate.Comment: the returned representative units did not display any adverse characteristics that would contribute to the defect the customer experienced.The defect described in the event description could not be confirmed or replicated with the returned representative units.The actual unit described in the incident report was not returned for evaluation.

Event Description

It was reported that the safety on a bd insyte¿ autoguard¿ shielded iv catheter did not function properly, leaving the needle exposed.There was no report of, injury or medical interventions.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED 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: 7060339
• MDR Text Key: 93708116
• Report Number: 1710034-2017-00394
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814344
• UDI-Public: 30382903814344
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 381434
• Device Lot Number: 7227517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2017
• 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