MAUDE Adverse Event Report: PROTEK MEDICAL PRODUCTS, INC. STERILE GENERAL PURPOSE PROBE COVER KIT; SURGICAL DRAPE

Model Number	1020
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On their 3500a report, the end user lists the lot number as #1915 and the expiration date as june 2022.However, that lot number has never been used by protek, and after reviewing manufacturing records, it was determined that protek also does not have an expiration date of june 2022 for this product.Protek has contacted the end user and is currently in the process of trying to clarify/confirm these details.Protek has also requested for the end user to provide a picture of the product labeling, and to return the probe cover involved in the event (if available), to be evaluated by protek.More investigation is in progress and additional information will be provided to fda as a follow-up report, when available.User facility report # (b)(4).
Event or Problem Description
According to the original reporter from (b)(6) hospital, the surgical team held open a sterile probe cover so that it could be inserted a transthoracic ultrasound probe.The probe was inserted and the surgeon began to perform an epicardial echocardiogram procedure.After the surgeon started to use the probe, he noticed a small hole in the probe cover, and the saline leaked out into the sterile field.He promptly handed back the probe and cover; a new cover was then used without incidence.
Additional Manufacturer Narrative
After contacting the end user, protek was informed that the product package and the cover used were no longer available to be returned or have photos taken; they were discarded after use.Due to not having the product or package available for evaluation and confirmation of the identification of the product, protek can only conclude that the product used by the hospital was not manufactured by protek - protek has no manufacturing records for the product reported (model #1020) with the lot number and expiration date provided by the end user on the original report.No actions needed at this time.
Event or Problem Description
According to the original reporter from (b)(6) hospital, the surgical team held open a sterile probe cover so that it could be inserted a transthoracic ultrasound probe.The probe was inserted and the surgeon began to perform an epicardial echocardiogram procedure.After the surgeon started to use the probe, he noticed a small hole in the probe cover, and the saline leaked out into the sterile field.He promptly handed back the probe and cover; a new cover was then used without incidence.

• Brand Name: STERILE GENERAL PURPOSE PROBE COVER KIT
• Common Device Name: SURGICAL DRAPE
• Manufacturer (Section D): PROTEK MEDICAL PRODUCTS, INC.; 4125 westcor court; coralville, ia IA 52241
• MDR Report Key: 9633668
• Report Number: 1934029-2020-00001
• Device Sequence Number: 2574902
• Product Code: KKX
• UDI-Device Identifier: 00841912104048
• UDI-Public: 00841912104048
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K970889
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1020
• Device Catalogue Number: 910810
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO
• Patient Weight: 4