MAUDE Adverse Event Report: HOLOGIC, INC ATEC; VACUUM ASSISTED CORE BIOPSY DEVICE

Model Number	0909-20
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned therefore, a failure analysis of the complaint device cannot be completed.If the device is returned and evaluation completed, a supplemental medwatch will be filed.Device history record (dhr) review was conducted for the reported identification number.The lot was released meeting all qa specifications.
Event or Problem Description
It was reported that when the protective cover was recapped, "the plastic part at the tip flew forward and blood entered the eyes." the "examinee was confirmed not infected." no additional details available.

• Brand Name: ATEC
• Common Device Name: VACUUM ASSISTED CORE BIOPSY DEVICE
• Manufacturer (Section D): HOLOGIC, INC; 250 campus drive; marlborough MA 01752
• MDR Report Key: 9556074
• Report Number: 1222780-2020-00003
• Device Sequence Number: 19683881
• Product Code: KNW
• UDI-Device Identifier: 35420045504848
• UDI-Public: (01)35420045504848(10)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: 0909-20
• Device Catalogue Number: 0909-20
• Device Lot Number: 19C14RC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 01/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other