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

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problems Erythema (1840); Itching Sensation (1943); Swelling (2091); Numbness (2415)

Event Date 02/18/2014

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as neither a catalog nor a lot number for this incident was provided.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.A sample was not returned for evaluation.

Event Description

It was reported that in preparation for a colonoscopy on (b)(6) 2014, a bd insyte utoguard shielded iv catheter was placed in a patient's right arm.While the nurse was performing the iv insertion, the patient heard a "snap".The nurse excused herself without finishing the iv insertion and stated that she needed a new iv because this one was giving her trouble.A second nurse came back to the patient and successfully inserted a new iv.The patient received his colonoscopy, which went smoothly, and the patient was discharged to home.A few days later, the patient developed redness, swelling, itching, and later noticed that when he bent his arm he could feel a prick of something in his arm at the location where the first iv was attempted.The patient went back to the physician that performed the colonoscopy and received x-rays of his arm and was told that the x-rays did not show a retained foreign object.The patent continued to feel a "poking" sensation in his arm so he had an ultrasound done which confirmed the presence of a foreign body in his arm.The patient was then evaluated by two vascular surgeons and his dermatologist.The second vascular surgeon performed a second ultrasound which again confirmed a retained foreign body.On (b)(6) 2014, the patient had surgery to remove the broken iv catheter from the vein in his right arm.Additionally, the patient has reported that he currently has no feeling in his arm related to this incident.

• 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: 5108634
• MDR Text Key: 26942370
• Report Number: 1710034-2015-00013
• Device Sequence Number: 1
• Product Code: FOZ
• 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: company representative,other
• Reporter Occupation: Attorney
• Report Date: 09/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention