MAUDE Adverse Event Report: COVIDIEN AW COLLECT SET FOR BACT ALERT; TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT

Model Number	8881225245
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the male blood culture hub with the internal needle are breaking off during collection.The customer further stated that the needle inside the hub seems to be less sturdy than before.After changing out the tubes, the needle would bend or break.There have been no exposures at this time.No harm to the clinician and the patient involved.

• Brand Name: AW COLLECT SET FOR BACT ALERT
• Common Device Name: TUBES, VACUUM SAMPLE, WITH ANTICOAGULANT
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9578424
• Report Number: 1282497-2020-08861
• Device Sequence Number: 11593037
• Product Code: GIM
• UDI-Device Identifier: 10884521013254
• UDI-Public: 10884521013254
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 8881225245
• Device Catalogue Number: 8881225245
• Device Lot Number: 192350051
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 01/10/2020
• Patient Sequence Number: 1