MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL

Catalog Number 382523

Device Problems Improper or Incorrect Procedure or Method (2017); Component Missing (2306); Device Or Device Fragments Location Unknown (2590)

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

Event Date 05/05/2016

Event Type  Injury  

Manufacturer Narrative

The medical device expiration date is unknown as the lot number is unknown.The device manufacture date is unknown as the lot number is unknown.Device evaluation: results - one used catheter unit without packaging was received for evaluation.The unit consisted of the catheter/adapter which had a miscellaneous extension line attached to it.There were traces of dried media.There was a transparent dressing adhered to the adapter portion of the returned sample.The remainder of the unit was not returned for evaluation and testing.A visual/microscopic evaluation revealed there was no catheter tubing protruding from the nose of the adapter, the separation was a break to the tubing that occurred at the end of the metal wedge, and the separation was on a slight angle and had uneven rough jagged edges.Conclusions - the returned device did not meet manufacturing specifications as there was an area of separation with rough jagged edges at the catheter tubing within the nose of the adapter.Confirmation of the defect was conclusive based on the evaluation of the returned unit.It was confirmed that the catheter tubing had been separated /broken within the nose of the adapter resulting in uneven rough jagged edges.There was no physical evidence to confirm or to support manufacturing process related issues for the reported defect.This incident is indeterminate.Although the defect was confirmed, a definite root cause could not be established.The uneven rough jagged edged at the separation was evidence of breakage stress and misuse.The information provided by the customer states ¿on (b)(6) @0025 per nurses notes: pt.Scratching at iv site in right breast ¿ dressing loose at one end.Upon inspection of iv site ¿ iv is out ¿ no catheter tip noted¿.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that the patient was initially admitted to the ocu, where the iv placed in the emergency department was discontinued by the patient inadvertently.On (b)(6) the patient was transported to the pcu.On (b)(6), the nurses notes report that the patient pulled another iv out and the tip was found intact.The suspect device was then placed by the nurse to the right side of the breast area on the first attempt.Per the nurses notes, on (b)(6) at 0025, "pt.Scratching at iv site in right breast, dressing loose at one end.Upon inspection of iv site, iv is out, no catheter tip noted." the bed and linens were searched but no catheter was found.Several x-rays (chest, right shoulder, right humerus, right forearm) were completed but the catheter was not detected.A consult was obtained per the hospitalist regarding the catheter.A right breast ultrasound and digital diagnostic mammogram were also completed.No catheter tip was detected.At the time of notification, the patient remains in the hospital on pcu.

• Brand Name: 22G X 1" BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BLOOD CONTROL
• Type of Device: SHIELDED IV 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: 5685459
• MDR Text Key: 46115429
• Report Number: 1710034-2016-00029
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 382523
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2016
• 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