MAUDE Adverse Event Report: COVIDIEN AW TRANSFER SET FOR BACT ALERT

Model Number 8881225241

Device Problems Crack (1135); Pressure Problem (3012)

Patient Problem Exposure to Body Fluids (1745)

Event Date 08/19/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 09/15/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a transfer set.The customer states an ed associate sustained blood spatter to their face while using a covidien transfer device to draw a routine blood sample from a young patient.The device was under pressure via the syringe vacuum.The associate was immediately treated.The customer reviewed what occurred and to the best of their knowledge they believe the connection between syringe and device was secure and a small crack possibly occurred at the nipple base.The cause is unclear at this time.They have performed this task numerous times and indicated they would not have changed any part of the technique.Multiple attempts have been made to the customer requesting information of the treatment that the ed associate received.However, the customer has not replied with the information to date.A supplemental report will be filed if the customer replies with the information.

Manufacturer Narrative

Submit date: 12/01/2016.The device history record was reviewed and indicated that the product was release accomplishing all quality standards.No sample was returned for evaluation only a picture indicating the possible location of the fault.A sample is required in order to verify the reported event or provide a more accurate root cause.No corrective actions will apply as no sample returned for evaluation.This complaint will be used for tracking and trending purposes.

• Brand Name: AW TRANSFER SET FOR BACT ALERT
• Type of Device: TRANSFER SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5952471
• MDR Text Key: 55163751
• Report Number: 1282497-2016-00687
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881225241
• Device Catalogue Number: 8881225241
• Device Lot Number: 152820334X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other