MAUDE Adverse Event Report: CAREFUSION OEM LARGEBORE SMARTPOCKET

Model Number 5600R

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that oem largebore smartpocket leaked.The following information was provided by the initial reporter: material no: p3068215 (5600r), batch no: 19058719.Harmac has received 2 complaints from the field for leaks from the needle free port.Becton dickenson lot number 19058719.The white lure cap is oval in shape and the leak is from the blue silicon.Scar01306 was logged against a similar part from becton dickenson, p3068205 needle free 'y' port for the same issue.7 field complaints for a oval white cap and a leak.To date no root cause was determined.Vendor should use this additional information to help determined root cause and take action so this issue does not repeat.

Manufacturer Narrative

Correction: this complaint was over reported, and the defect was already reported with mdr# 9616066-2020-02441.- attachment: [pr# 384216 - cancellation.Msg].

Event Description

It was reported that oem largebore smartpocket leaked.The following information was provided by the initial reporter: material no: p3068215 (5600r).Batch no: 19058719.Harmac has received 2 complaints from the field for leaks from the needle free port.Becton dickenson lot number 19058719.The white lure cap is oval in shape and the leak is from the blue silicon.Scar01306 was logged against a similar part from becton dickenson, p3068205 needle free 'y' port for the same issue.7 field complaints for a oval white cap and a leak.To date no root cause was determined.Vendor should use this additional information to help determined root cause and take action so this issue does not repeat.

• Brand Name: OEM LARGEBORE SMARTPOCKET
• Type of Device: NA
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 10372864
• MDR Text Key: 233926518
• Report Number: 9616066-2020-02447
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• PMA/PMN Number: 2020-06-23
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 5600R
• Device Catalogue Number: 5600R
• Device Lot Number: 19058719
• Was Device Available for Evaluation?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other