MAUDE Adverse Event Report: GREATBATCH MEDICAL KIT 7FR PTFE INTRO 5PK BIOTRONIK, LI-7 PLUS; INTRODUCER, CATHETER

Model Number	10773-010
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A containment action has been initiated to inspect all affected inventory.The follow-up report will contain the result of the containment action as well as dhr reviews and other investigation actions that will take place.
Event or Problem Description
A hair was found when the device package was opened.The device was not used.There was no adverse patient impact.
Additional Manufacturer Narrative
Resorting of the lots in hand was performed.Nonconformance reports were generated and released to document this process.

• Brand Name: KIT 7FR PTFE INTRO 5PK BIOTRONIK, LI-7 PLUS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): GREATBATCH MEDICAL; 2300 berkshire lane; minneapolis, mn
• MDR Report Key: 9799498
• Report Number: 2183787-2020-00030
• Device Sequence Number: 643530
• Product Code: DYB
• UDI-Device Identifier: 00821329400360
• UDI-Public: (01)00821329400360(17)210611(10)GB4919754
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2020

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: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 10773-010
• Device Catalogue Number: N/A
• Device Lot Number: GB4919754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1