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

Catalog Number 382623

Device Problems Break (1069); Material Twisted/Bent (2981)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/13/2018

Event Type  Injury  

Manufacturer Narrative

Medwatch report # mw5080088.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter with bc there was an issue with catheter tip integrity and separation.Upon piercing the patient's skin the patient began to bleed around the catheter and the catheter was pulled out.Nurse noted the tip was bent and that a piece of the catheter tip was broken off.Anesthesia ordered a hand and chest x-ray which confirmed no trace of the missing catheter piece.

Manufacturer Narrative

Investigation summary: observations and testing could not be performed because units were not received for investigation of this incident.A complaint history check was performed, and this is the 1st related complaint reported with the defect/condition of catheter broke/separated after placement with lot #8114638 regarding item #: (b)(4).This is the 2nd related complaint reported with the defect/condition of catheter tip integrity with lot #: 8114638 regarding item #: (b)(4).Dhr review was performed on lot number: 8114638.The lot number was built on afa line 10 from 26apr18 thru 29apr18.Packaged on packaging line 10 from 1may18 thru 2may18 and then again on 14may18.Review of dhr revealed all required challenge samples, set-up and in process testing was perform in accordance with the quality plans.Review disclosed one non-related qn was initiated during the build of this lot that would not impact the outcome of the quality of the product relevant to the defect stated in the pir.Without the actual sample for evaluation and testing there was no physical evidence to confirm or support manufacturing process related issues for the reported defect.The peura (end user risk analysis) was analyzed to determine the risk to customer.The analysis showed that current risk is acceptable.Occurrence and severity rankings have not changed.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated monthly.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 with the use of the bd insyte¿ autoguard¿ bc shielded iv catheter with bc there was an issue with catheter tip integrity and separation.Upon piercing the patient's skin the patient began to bleed around the catheter and the catheter was pulled out.Nurse noted the tip was bent and that a piece of the catheter tip was broken off.Anesthesia ordered a hand and chest x-ray which confirmed no trace of the missing catheter piece.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WITH BC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8065479
• MDR Text Key: 127051430
• Report Number: 1710034-2018-00825
• Device Sequence Number: 0
• Product Code: FOZ
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 382623
• Device Lot Number: 8114638
• Date Manufacturer Received: 10/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0
• Patient Outcome(s): Required Intervention