MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 381433

Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 06/22/2017

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.The initial reporter also notified the fda on 07/17/2017 via medwatch (b)(4).Device manufacture date: unknown (b)(4).

Event Description

It was reported that as the patient moved in bed, the hub of the 20 g x 1.00 in.Bd insyte¿ autoguard¿ shielded iv catheter dislodged leaving part of the catheter in the patient¿s vein.Patient was sent to vascular surgery where 1.8cm of the catheter was retrieved from the patient¿s right antecubital subcutaneous tissue.

Manufacturer Narrative

Investigation: received one used 20g insyte autoguard iv catheter unit without packaging.The unit consisted of the catheter/adapter assembly with only a small portion of the catheter tubing protruding beyond the nose of the adapter.A miscellaneous ex-tube was attached at the end of the adapter.The ex-tube was looped and there were tape strips and a transparent dressing adhered to the ex-tube and the adapter portion of the used unit (catheter/adapter assy.) there were traces of dried media present on the unit.The unit was attached to a miscellaneous extension line w/and miscellaneous injection site.Visual/microscopic evaluation revealed the area of separation at the catheter tubing had jagged and rough edges with indication of stress.Measurement revealed; there was approximately 0.305¿ tubing protruding from the nose of the adapter to the highest point of the tubing.A review of the device history record could not be performed as a lot number was not provided for this incident.Confirmation of the defect of catheter broke, as stated in the product incident report, was conclusive based on the evaluation of the unit provided for this incident.Confirmed the catheter tubing had been separated (broken) by excessive stress resulting in rough, jagged edges.The tubing was at approximately 0.305¿ from the nose of the adapter to the highest point in the tubing at the area of separation.There was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir.This incident is indeterminate.Confirmation of the customer¿s experience with the bd product was conclusive based on the review of the returned unit.The root cause was determined to be separation by stress in the clinical setting; the rough jagged edges and stress to the area of separation were indicative of excessive stress to the.

• Brand Name: 20 G X 1.00 IN. 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: 6817894
• MDR Text Key: 83538659
• Report Number: 1710034-2017-00144
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

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: Other
• Device Catalogue Number: 381433
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/24/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 09/29/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 126