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

Catalog Number 381423

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that erroneous results occurred after use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, it was reported that collection of blood from a syringe connected to the catheter is resulting in erroneous results.The account converted t k2edta tubes not made by bd ( 2ml 454428 lot b19013up exp date 05-17-2020) due to previous issues with bd tubes.Since, the conversion they continued to have similar issues with erroneous hgb results.They want to learn if there may be blood collection techniques that may be contributing to their current preanalytical issues.She explained the techniques by er.Patient collected if the results were low the physician requested a recollect by phlebotomy staff, which resulted in an increased hgb result.Another collection method by er was with a 10cc bd syringe (302995) connected directly to bd insyte catheter ( cat# to follow) adapter was used to transfer to tubes.Hgb results were low, phlebotomy recollected and results normal.Another scenario syringe with wingset 23 g (367283 lot 9c0191 exp date 03-31-2022).Again results were unreliable, the redraw was with slbcs and holder resulted in acceptable results.Stated that tubes were not hemolyzed but could note a difference in red cell volume, tubes filled adequately but not sure of the total number of inversions.No extension sets are used with line draws when multiple tubes were collected and the cbc results were questioned, then all tubes were recollected.The edta tubes were retested on another analyzer and resulted repeated.To support this customer reviewed importance of proper use of syringe and transfer, collection from line, and proper techniques with mixing and handling the tubes., the customer expressed interest in coming back to bd and would like further assistance with best practice materials and training." 1 of 3 complaints.

Manufacturer Narrative

Investigation: since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.The complaint could not be confirmed and root cause is undetermined.

Event Description

It was reported that erroneous results occurred after use with a bd insyte¿ autoguard¿ shielded iv catheter.The following information was provided by the initial reporter, it was reported that collection of blood from a syringe connected to the catheter is resulting in erroneous results.The account converted t k2edta tubes not made by bd ( 2ml 454428 lot b19013up exp date 05-17-2020) due to previous issues with bd tubes.Since, the conversion they continued to have similar issues with erroneous hgb results.They want to learn if there may be blood collection techniques that may be contributing to their current preanalytical issues.She explained the techniques- er patient collected if the results were low the physician requested a recollect by phlebotomy staff, which resulted in an increased hgb result.Another collection method by er was with a 10cc bd syringe (302995) connected directly to bd insyte catheter ( cat# to follow) adapter was used to transfer to tubes.Hgb results were low, phlebotomy recollected and results normal.Another scenerio syringe with wingset 23 g (367283 lot 9c0191 exp date 03-31-2022).Again results were unreliable, the redraw was with slbcs and holder resulted in acceptable results.Stated that tubes were not hemolyzed but could note a difference in red cell volume, tubes filled adequately but not sure of the total number of inversions.No extension sets are used with line draws when multiple tubes were collected and the cbc results were questioned, then all tubes were recollected.The edta tubes were retested on another analyzer and resulted repeated.To support this customer reviewed importance of proper use of syringe and transfer, collection from line, and proper techniques with mixing and handling the tubes., the customer expressed interest in coming back to bd and would like further assistance with best practice materials and training." 1 of 3 complaints.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9100551
• MDR Text Key: 166145946
• Report Number: 1710034-2019-01030
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 50382903814232
• UDI-Public: 50382903814232
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: 381423
• Device Lot Number: 9158582
• Date Manufacturer Received: 08/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other