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

Catalog Number 382523

Device Problem Problem with Sterilization (1596)

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

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

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 there was an issue with sterile breach.There was no report of injury or medical intervention.

Event Description

It was reported with the use of the bd insyte autoguard bc shielded iv catheter there was an issue with sterile breach.There was no report of injury or medical intervention.

Manufacturer Narrative

Dhr- the lot was manufactured on afa line 12 with a total amount of (b)(4) units from 12apr18 through 15apr18.3 non related qn¿s (200743618- no lube on actuator, 200743559 & 200744920 shallow plugs) were initiated during production.Disposition, root cause and corrective action were applied as per quality control plan.All other challenge, set up and in process samples were performed and passed per specifications.Received 5 iag packages from lot number 8100611.The packages were marked with pink highlight.Visual/microscopic evaluation: pockets 6 through 10 were received.Pockets 6, 7 and 9 displayed a small hole (approx.2.00 mm2 ) on the top web paper.Pocket 7 displayed a tear (approx.62mm) on the top web paper.No damage was observed on the seal of the packages.Indeterminate: although the failure experience was confirmed with the received units, a definite source that caused the damage on the top web could not be determined.It is not known if it was caused by the manufacturing process, during transit/handling or at the user setting.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 7965859
• MDR Text Key: 124192455
• Report Number: 1710034-2018-00712
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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: 382523
• Device Lot Number: 8100611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Date Manufacturer Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other