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

Catalog Number 382533

Device Problem Material Integrity Problem (2978)

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

Event Date 03/08/2019

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 the catheter of a bd¿ insyte autoguard bc had tiny piece of plastic at the end of cannula.Customer¿s verbatim: "the two this morning were ref # (b)(4) and lot # 8256535 and we packaged up that lot but now we just had another one and it is same ref # but lot 8197518.Very concerning when nurses open these packages and there are tiny pieces of plastic loose on the ends.".

Event Description

It was reported that the catheter of a bd¿ insyte autoguard bc had tiny piece of plastic at the end of cannula.Customer¿s verbatim: ¿ the two this morning were ref # 382533 and lot # 8256535 and we packaged up that lot but now we just had another one and it is same ref # but lot 8197518.Very concerning when nurses open these packages and there are tiny pieces of plastic loose on the ends.¿.

Manufacturer Narrative

Investigation summary: dhr: a total of (b)(6) units were built/packaged on afa line 11 from 19jul2018 through 25jul18.No qns were initiated during production all challenge, set up and in process samples were performed per specifications.Received 40 sealed packages and one used unit from with an open-empty package from lot# 8197518.Visual/microscopic evaluation: sealed packages: all units were visually inspected, no evidence of particles or foreign matter could be found on any of the components of the representative samples received.Open unit: several dark colored fibers were found on the tip of the catheter but the fm (white speck) displayed on the pictures received was not found.No evidence of the foreign matter (white speck) displayed on the pictures could be found on the open unit received for evaluation.A thorough visual evaluation was performed on the plastic bag where the unit was received and no evidence of the white speck was found either.Pictures: the pictures returned for review display a 20ga iag unit which reveals a white speck on the catheter tubing.Conclusion(s): indeterminate: although the pictures received for evaluation confirm the presence of a white speck on the catheter tubing the source and root cause could not be determined since the picture does not reveal a microscopic image of the material.The colored fibers found on the catheter tubing (not visible on the pictures or signaled by customer) could have been introduced to the unit either during the mfg.Process, at the user environment or during handling/transit back to the lab.Ftir testing could not be performed on the dark fibers found on the catheter tip since the specks were too small to be tested.

• Brand Name: BD¿ INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 8466059
• MDR Text Key: 140655809
• Report Number: 1710034-2019-00353
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825333
• UDI-Public: 30382903825333
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• 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: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 382533
• Device Lot Number: 8197518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other