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

Model Number 8881225241

Device Problem Mechanics Altered (2984)

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

Event Date 04/10/2016

Event Type  malfunction  

Manufacturer Narrative

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 syringe.The customer states a technician was removing an angel wing from its packaging when he noticed the needle was detached from the protective casing.The point supervisor was notified.No patient was involved and no impact to the procedure or clinician.The product was being used for sterility testing on blood sample.

Manufacturer Narrative

The customer states a technician was removing an angel wing from its packaging when he noticed the needle was detached from the protective casing.The point supervisor was notified.No patient was involved and no impact to the procedure or clinician.The product was being used for sterility testing on blood sample.The report refers to product code 8881225241- female blood culture transfer with lot number 152190284x.The dhr of the lot number reported was reviewed, and was confirmed that the products were produced accomplishing quality requirements and was released according to established procedures.There was received one sample for evaluation, sample showed that the needle was detached from the holder; it seems that material was not properly assembled during manufacturing process.Root cause could be related to misalignment during the pneumatic press process.A quality circle was opened to follow up this issue, actions were the following: maintenance order to level de press.Personnel were retrained on procedure related to needle press.A poka-yoke was implemented on work station.

• 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; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st.; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5648063
• MDR Text Key: 45516978
• Report Number: 1282497-2016-00198
• Device Sequence Number: 1
• Product Code: KSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881225241
• Device Catalogue Number: 8881225241
• Device Lot Number: 52190284X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1