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

Catalog Number 381434

Device Problems Fluid/Blood Leak (1250); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Code Available (3191)

Event Date 04/06/2016

Event Type  Injury  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that after having placed a bd insyte¿ autoguard¿ shielded iv catheter in a patient, the patient called out and said that she had bumped her iv on something and that it had begun to leak.Upon assessment, iv fluid was seen filling under tegaderm dressing which was sealed completely around iv site.When the tegaderm was peeled off it appeared that the hub of the catheter was present, but there was no catheter.The catheter was no felt under the patient's skin nor found in the room after a thorough search was made.The patient received an x-ray of her hand, forearm, and chest, a ct scan of her chest, and an ultrasound of her arm.All imaging studies were negative for a retained foreign body.

Manufacturer Narrative

Additional information: three additional lot numbers were added as potential lot numbers for this incident when samples were returned for evaluation.The information for these lot numbers is as follows: catalog #: 381434, lot #: 5295695, expiration date: 9/30/2018, device manufacture date: 10/22/2015.Catalog #: 381434, lot #: 5187598, expiration date: 6/30/2018, device manufacture date: 7/6/2015.Catalog #: 381434, lot #: 6007733, expiration date: 12/31/2018, device manufacture date: 1/7/2016.Device evaluation: results: for lot # 5355991: a visual inspection revealed one unused unit in a sealed package and one used adapter/wedge assembly attached to a dual legged iv tubing were received for evaluation.A microscopic inspection of the unused unit reveled no bends, holes, kinks, splits, or wrinkles in the catheter tubing, nor the characteristic v shape of a spear through in the unused unit.A microscopic inspection of the used unit revealed no mechanical/physical damage to adapter/wedge assembly and there was no residual tubing material attached to the wedge.No catheter tubing was returned for evaluation.A water/air leak test was performed on both used and unused units.No leakage in any area of the catheter/adapter assembly of the unused unit was observed.Leakage was observed coming from the nose of the adapter for the used unit.A catheter pull force test was conducted on the unused unit and the catheter passed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5355991.For lot # 5295695: a visual inspection revealed one unused unit in a sealed package.A microscopic inspection of the unused unit reveled no bends, holes, kinks, splits, or wrinkles in the catheter tubing, nor the characteristic v shape of a spear through in the unused unit.A water/air leak test was performed and no leakage in any area of the catheter/adapter assembly was observed.A catheter pull force test was conducted and the catheter passed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5295695.For lot # 5187598: a visual inspection revealed one unused unit in a sealed package.A microscopic inspection of the unused unit reveled no bends, holes, kinks, splits, or wrinkles in the catheter tubing, nor the characteristic v shape of a spear through in the unused unit.A water/air leak test was performed and no leakage in any area of the catheter/adapter assembly was observed.A catheter pull force test was conducted and the catheter passed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 5187598.For lot # 6007733: a visual inspection revealed one unused unit in a sealed package.A microscopic inspection of the unused unit reveled no bends, holes, kinks, splits, or wrinkles in the catheter tubing, nor the characteristic v shape of a spear through in the unused unit.A water/air leak test was performed and no leakage in any area of the catheter/adapter assembly was observed.A catheter pull force test was conducted and the catheter passed.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6007733.Conclusion: an absolute root cause for this incident cannot be determined.Although bd confirmed that the used unit had a broken catheter, the catheter tubing was not provided for investigation.Additionally, bd was not able to reproduce the customer's experience with of any of the unused products.

• 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: 5585536
• MDR Text Key: 42942570
• Report Number: 1710034-2016-00022
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2016

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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 381434
• Device Lot Number: 5355991
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2016
• Initial Date FDA Received: 04/18/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2015
• 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