MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ 22G X 1.0 IN; INTRAVASCULAR CATHETER

Catalog Number 381823

Device Problems Break (1069); Component Missing (2306)

Patient Problems Cellulitis (1768); Pain (1994); Swelling (2091)

Event Date 01/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The medical device expiration date is unknown as the lot number is unknown.(b)(6).The device manufacture date is unknown as the lot number is unknown.Device evaluation: result - bd received one used 22g iag catheter unit without packaging.The unit consisted of the adapter with a very small portion of catheter tubing protruding beyond the nose of the adapter.The unit had a dual injection line attached to the end of the adapter.There was a transparent dressing wrapped around the adapter.There were traces of dried media.The remainder of the unit was not returned for evaluation.A visual examination was performed.The tubing measured approximately 0.0287¿ from the nose of the adapter to the area of separation.The area of separation was on an angle and revealed the characteristics of a smooth cut (edges) to the tubing.There were no scratches or scuff markings to any area of the catheter tubing wall.A review of the device history record cannot be completed as the lot number was not provided for this incident.Conclusion - a definite root cause could not be established.The cut with smooth edges and at the catheter tubing are evidence of misuse.It is uncertain whether the defects experienced by the customer were contributed to by manipulation of the device prior to insertion or by the manufacturing process.Where the defect occurred (clinical environment or manufacturing) is indeterminate.

Event Description

It was reported that the patient was admitted to sw2 (surgical unit) on (b)(6) 2017 for cellulitis to the right hand and removal of cannula that was retained in her arm 7 years ago.The suspect device was placed by an anesthetist to the patient's left ankle (at a point of flexion) midday on the day of admission.The insertion was noted to be successful upon first attempt, reporting the catheter/stylet was not withdrawn at any time during the procedure.On (b)(6) 2017, the patient rang her bell and requested to have her infusion reconnected to her iv.The nurse flushed the suspect device with normal saline 5ml and the patient complained of pain.The flush was stopped and the site was checked by removing the bandage.Leakage was noted and when the nurse removed the tegaderm dressing to remove the device, the tip of the cannula was missing.At 0740, after patient handover was finished, the nurse who initially discovered the missing cannula called an additional nurse to assess the iv site.This nurse noted the tegaderm had been pulled halfway from the site and noted the "front part of the loop missing and not visible, only the end part and the claves (sp)" could been seen.The site was palpated, which proved very painful and minimal swelling was noted to the ankle area.The nurse did not feel anything under the skin upon palpation and no bleeding was noted.The doctor was notified and x-rays were ordered.Results of a left limb ultrasound showed hyperechoic cannulated structure to the medial ankle in the subcutaneous soft tissue.The patient reported severe pain over the next 12 hours and was given dicloflame, tramacet, and tramal for the pain.Surgery was performed to remove the broken catheter.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 22G X 1.0 IN
• 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: 6344409
• MDR Text Key: 67819985
• Report Number: 1710034-2017-00040
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2017

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?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 381823
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/20/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR