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

Catalog Number 382523

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problems Tissue Damage (2104); Test Result (2695)

Event Date 10/07/2015

Event Type  Injury  

Manufacturer Narrative

(b)(6).Evaluation: a device is available for investigation but has not been received by the manufacturer.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that a bd insyte autoguard bc shielded iv catheter was placed intraoperatively without difficulty by an experienced anaesthetist.It was noted by the icu nurse 24 hours later that fluid was leaking from around the hub and under the dressing.The tagederm dressing was peeled back to inspect the insertion site and the iv hub was found sitting on the skin with the cannula missing.The patient received an x-ray to locate the broken cannula.It was found further up the limb and a surgical incision under local anesthesia was required to remove the broken piece.

Manufacturer Narrative

Results - a review of the device history record revealed no abnormalities during the manufacture of the reported lot number 5111723.Two samples were returned for evaluation and were inspected under visual/microscopic examination.One unused sample in the original, sealed package was received.There were no bends, holes, kinks, splits or wrinkles in the catheter tubing; nor the characteristic v shape of a spear through.The tubing did not separate from the adapter when the needle was retracted.A pull force test was performed and the sample passed specification.One used catheter/adapter assembly with an attached needleless connector was received in two portions.On the portion of the catheter attached to adapter, it was observed that there was approximately ¼ inch of catheter tubing protruding from the nose of the adapter.The piece of loose tubing was noted to be approximately ¾ inch long.The tubing edges are sharp, jagged, and in a v shape pattern.The adapter and the loose tubing were pieced back together and show that the v shape patterns align.Conclusion- the reported defect was confirmed with the returned unit.The evidence provided does not deliver confirmation that the catheter was not functioning correctly during the period of infusion.It is uncertain whether the defect observed was caused by use of sharp object or instrument, manipulation of the device prior to insertion, or by the manufacturing process.Therefore, an absolute root cause for this incident cannot be determined.

Manufacturer Narrative

Additional information: a second device evaluation was performed by the manufacturer site on 11/25/2015.The evaluation confirmed that a separation occurred in the catheter tubing as a result of a spear through by the cannula.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER 22 G X 1 IN.
• 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: 5174379
• MDR Text Key: 29199849
• Report Number: 1710034-2015-00016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2015

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: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 382523
• Device Lot Number: 5111723
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 10/24/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/19/2015; 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2015
• 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